<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02995915</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00062101</org_study_id>
    <nct_id>NCT02995915</nct_id>
  </id_info>
  <brief_title>Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking</brief_title>
  <official_title>Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol misuse and smoking constitute two of the three leading preventable causes of death in&#xD;
      the United States. The purpose of this research study is to develop an intervention designed&#xD;
      to help people stop drinking alcohol and stop smoking at the same time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol misuse and smoking constitute two of the three leading preventable causes of death in&#xD;
      the United States. Reluctance to treat tobacco dependence among those with AUD is misguided&#xD;
      as recent research suggests smoking cessation treatment can be effective, does not increase&#xD;
      risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence&#xD;
      for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It&#xD;
      is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals&#xD;
      misusing substances contingent upon objective evidence from drug use. Implementation of CM&#xD;
      has been limited because of the need to verify abstinence multiple times daily using clinic&#xD;
      based monitoring. The investigators recently developed a smart-phone application which allows&#xD;
      a patient to video themselves several times daily while using a small CO monitor and to&#xD;
      transmit the data to a secure server which has made the use of CM for outpatient smoking&#xD;
      cessation portable and feasible. This mobile CM (mCM) approach paired with&#xD;
      cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective&#xD;
      in reducing smoking.&#xD;
&#xD;
      Thus, the purpose of this project is to develop a combined alcohol and smoking mCM&#xD;
      intervention. The intervention will be developed in two successive cohorts of five&#xD;
      participants, who will provide information on treatment acceptability and feasibility. A&#xD;
      third cohort of participants (n=45) will participate in a randomized clinical trials to&#xD;
      further examine feasibility and efficacy. The long term goal is to develop mCM procedures&#xD;
      that will be used as part of a multi-component intervention to concurrently and effectively&#xD;
      treat both alcohol misuse and smoking. As part of this project, the investigators will&#xD;
      develop a multi-component telehealth alcohol and smoking mCM intervention. It will include&#xD;
      mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy.&#xD;
      The work proposed in these aims will provide the first step toward implementation of an&#xD;
      innovative approach that builds upon the power of mHealth technology to reduce the prevalence&#xD;
      of both alcohol misuse and smoking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 2, 2020</completion_date>
  <primary_completion_date type="Actual">March 2, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Smoking</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will be asked to report on smoking since two weeks past quit date</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will be asked to report on smoking and alcohol use since two weeks past quit date</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Self-reported prolonged abstinence from smoking will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>7-day point prevalence abstinence is defined as no smoking in the prior 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>30-day point prevalence abstinence is defined as no smoking in the prior 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will self-report number of days drank alcohol in the past 30 days and this will be compared to self-reported number of days drank alcohol in 30 days prior to quit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will self-report number of alcoholic beverages consumed in past 7 days and this will be compared to self-reported number of alcoholic beverages consumed in 7 days prior to quit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will self-report number of heavy drinking episodes in the past 30 days and this will be compared to self-reported number of heavy drinking episodes in 30 days prior to quit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women)</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will be asked to report on alcohol use in past week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Average Cigarettes Smoked Per Day</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will self-report average number of cigarettes smoked in the past week and this will be compared to self-reported number of smoked in the week prior to quit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use</measure>
    <time_frame>6 month follow-up</time_frame>
    <description>Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked 30 days prior to quit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Participants will be asked to report on smoking since two weeks past quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
    <description>Participants will be asked to report on smoking since two weeks past quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</measure>
    <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
    <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Smoking</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report Prolonged Abstinence From Smoking</measure>
    <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
    <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Participants will be asked to report on smoking since two weeks past quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</measure>
    <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
    <description>Participants will be asked to report on smoking since two weeks past quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Smoking Quit Attempts</measure>
    <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
    <description>Participants will be asked to report the number of quit attempts made since quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Smoking Quit Attempts</measure>
    <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
    <description>Participants will be asked to report the number of quit attempts made since quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Smoking Quit Attempts</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Participants will be asked to report the number of quit attempts made since quit date</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Alcohol Drinking</condition>
  <arm_group>
    <arm_group_label>Tele-health Mobile Contingency Management Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm includes a proactive tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, a tele-medicine clinic for access to smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tele-health for Alcohol and Smoking Cessation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm includes a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and tele-medicine clinic for access to smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants will receive monetary compensation for each assessment, regardless of abstinence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nicotine Replacement Therapy</intervention_name>
    <description>Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings</description>
    <arm_group_label>Tele-health Mobile Contingency Management Intervention</arm_group_label>
    <arm_group_label>Tele-health for Alcohol and Smoking Cessation</arm_group_label>
    <other_name>nicotine gum, patch, inhaler, and/or lozenge</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.</description>
    <arm_group_label>Tele-health Mobile Contingency Management Intervention</arm_group_label>
    <arm_group_label>Tele-health for Alcohol and Smoking Cessation</arm_group_label>
    <other_name>Zyban</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Treatment</intervention_name>
    <description>Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.</description>
    <arm_group_label>Tele-health Mobile Contingency Management Intervention</arm_group_label>
    <arm_group_label>Tele-health for Alcohol and Smoking Cessation</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Contingency Management</intervention_name>
    <description>Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
    <arm_group_label>Tele-health Mobile Contingency Management Intervention</arm_group_label>
    <other_name>mobile CM, mCM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Monitoring</intervention_name>
    <description>Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
    <arm_group_label>Tele-health for Alcohol and Smoking Cessation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently meet criteria for DSM-5 mild to moderate alcohol use disorder (meeting 2-5&#xD;
             criteria for AUD)&#xD;
&#xD;
          -  have been engaging in hazardous drinking over the past month, defined as either&#xD;
             exceeding a mean of 14 standard drinks/wk for men, 7 drinks/wk for women; or by&#xD;
             consuming &gt;5 on at least one occasion in the last month for men, &gt;4 drinks on at least&#xD;
             one occasion in the last month for women&#xD;
&#xD;
          -  currently smoke &gt;10 cigarettes a day, and have smoked for at least one year&#xD;
&#xD;
          -  can speak and write fluent conversational English&#xD;
&#xD;
          -  are willing to make an attempt to quit both alcohol and smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are expected to have unstable medication regimen during the study&#xD;
&#xD;
          -  are currently receiving non-study behavioral treatment for alcohol use disorder or&#xD;
             smoking&#xD;
&#xD;
          -  have severe alcohol use disorder (meeting &gt;6 criteria for AUD or having alcohol&#xD;
             withdrawal symptom criterion)&#xD;
&#xD;
          -  have AUD that is in early remission, with no symptoms evident over the past month&#xD;
&#xD;
          -  have experienced myocardial infarction in past 6 months&#xD;
&#xD;
          -  contraindication to nicotine replacement therapy with no medical clearance to&#xD;
             participate in the study&#xD;
&#xD;
          -  use other forms of nicotine such as cigars, pipes, or chewing tobacco&#xD;
&#xD;
          -  are currently pregnant&#xD;
&#xD;
          -  have a primary psychotic disorder or current manic episode&#xD;
&#xD;
          -  have had substance use disorder (other than alcohol or nicotine) in the preceding 3&#xD;
             months&#xD;
&#xD;
          -  are currently imprisoned or in psychiatric hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric A. Dedert, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>February 23, 2021</results_first_submitted>
  <results_first_submitted_qc>April 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 28, 2021</results_first_posted>
  <last_update_submitted>April 1, 2021</last_update_submitted>
  <last_update_submitted_qc>April 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02995915/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02995915/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tele-health Mobile Contingency Management Intervention</title>
          <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
        </group>
        <group group_id="P2">
          <title>Tele-health for Alcohol and Smoking Cessation</title>
          <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tele-health Mobile Contingency Management Intervention</title>
          <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
        </group>
        <group group_id="B2">
          <title>Tele-health for Alcohol and Smoking Cessation</title>
          <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.77" spread="11.39"/>
                    <measurement group_id="B2" value="42.67" spread="11.46"/>
                    <measurement group_id="B3" value="42.73" spread="11.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
        <description>Participants will be asked to report on smoking since two weeks past quit date</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
          <description>Participants will be asked to report on smoking since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified</title>
        <description>Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified</title>
          <description>Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
        <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
          <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</title>
        <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
        <time_frame>6 month follow-up</time_frame>
        <population>This subset of participants self-reported prolonged abstinence from alcohol.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</title>
          <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
          <population>This subset of participants self-reported prolonged abstinence from alcohol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol</title>
        <description>Participants will be asked to report on smoking and alcohol use since two weeks past quit date</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol</title>
          <description>Participants will be asked to report on smoking and alcohol use since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified</title>
        <description>Self-reported prolonged abstinence from smoking will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
        <time_frame>6 month follow-up</time_frame>
        <population>This subset of participants self-reported dual abstinence from alcohol use and smoking.</population>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified</title>
          <description>Self-reported prolonged abstinence from smoking will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
          <population>This subset of participants self-reported dual abstinence from alcohol use and smoking.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
        <description>7-day point prevalence abstinence is defined as no smoking in the prior 7 days.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
          <description>7-day point prevalence abstinence is defined as no smoking in the prior 7 days.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking</title>
        <description>30-day point prevalence abstinence is defined as no smoking in the prior 30 days</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking</title>
          <description>30-day point prevalence abstinence is defined as no smoking in the prior 30 days</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use</title>
        <description>Participants will self-report number of days drank alcohol in the past 30 days and this will be compared to self-reported number of days drank alcohol in 30 days prior to quit.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use</title>
          <description>Participants will self-report number of days drank alcohol in the past 30 days and this will be compared to self-reported number of days drank alcohol in 30 days prior to quit.</description>
          <units>drinking days per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.67" spread="9.68"/>
                    <measurement group_id="O2" value="-10.3" spread="10.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use</title>
        <description>Participants will self-report number of alcoholic beverages consumed in past 7 days and this will be compared to self-reported number of alcoholic beverages consumed in 7 days prior to quit.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use</title>
          <description>Participants will self-report number of alcoholic beverages consumed in past 7 days and this will be compared to self-reported number of alcoholic beverages consumed in 7 days prior to quit.</description>
          <units>drinks per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.53" spread="17.54"/>
                    <measurement group_id="O2" value="-13.9" spread="17.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use</title>
        <description>Participants will self-report number of heavy drinking episodes in the past 30 days and this will be compared to self-reported number of heavy drinking episodes in 30 days prior to quit.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use</title>
          <description>Participants will self-report number of heavy drinking episodes in the past 30 days and this will be compared to self-reported number of heavy drinking episodes in 30 days prior to quit.</description>
          <units>heavy drinking episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.22" spread="10.22"/>
                    <measurement group_id="O2" value="-11.00" spread="9.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women)</title>
        <description>Participants will be asked to report on alcohol use in past week</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women)</title>
          <description>Participants will be asked to report on alcohol use in past week</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
        <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
          <description>Participants will be asked to report on alcohol use since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</title>
        <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified</title>
          <description>Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Average Cigarettes Smoked Per Day</title>
        <description>Participants will self-report average number of cigarettes smoked in the past week and this will be compared to self-reported number of smoked in the week prior to quit.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Average Cigarettes Smoked Per Day</title>
          <description>Participants will self-report average number of cigarettes smoked in the past week and this will be compared to self-reported number of smoked in the week prior to quit.</description>
          <units>cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.56" spread="7.45"/>
                    <measurement group_id="O2" value="-5.30" spread="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use</title>
        <description>Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked 30 days prior to quit.</description>
        <time_frame>6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use</title>
          <description>Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked 30 days prior to quit.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.22" spread="10.98"/>
                    <measurement group_id="O2" value="-4.70" spread="11.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
        <description>Participants will be asked to report on smoking since two weeks past quit date</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
          <description>Participants will be asked to report on smoking since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
        <description>Participants will be asked to report on smoking since two weeks past quit date</description>
        <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking</title>
          <description>Participants will be asked to report on smoking since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
        <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
        <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use</title>
          <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
        <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
          <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
        <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
        <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report Prolonged Abstinence From Smoking</title>
          <description>Participants will be asked to report on alcohol use since two weeks past quit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</title>
        <description>Participants will be asked to report on smoking since two weeks past quit date</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</title>
          <description>Participants will be asked to report on smoking since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</title>
        <description>Participants will be asked to report on smoking since two weeks past quit date</description>
        <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking</title>
          <description>Participants will be asked to report on smoking since two weeks past quit date</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Smoking Quit Attempts</title>
        <description>Participants will be asked to report the number of quit attempts made since quit date</description>
        <time_frame>6 week follow-up (i.e., end of treatment visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Smoking Quit Attempts</title>
          <description>Participants will be asked to report the number of quit attempts made since quit date</description>
          <units>smoking quit attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="6.58"/>
                    <measurement group_id="O2" value="0.86" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Smoking Quit Attempts</title>
        <description>Participants will be asked to report the number of quit attempts made since quit date</description>
        <time_frame>8 week follow-up (i.e., Session 7, end of monitoring visit)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Smoking Quit Attempts</title>
          <description>Participants will be asked to report the number of quit attempts made since quit date</description>
          <units>smoking quit attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="1.03"/>
                    <measurement group_id="O2" value="4.11" spread="9.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Smoking Quit Attempts</title>
        <description>Participants will be asked to report the number of quit attempts made since quit date</description>
        <time_frame>6-month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tele-health Mobile Contingency Management Intervention</title>
            <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
          </group>
          <group group_id="O2">
            <title>Tele-health for Alcohol and Smoking Cessation</title>
            <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Smoking Quit Attempts</title>
          <description>Participants will be asked to report the number of quit attempts made since quit date</description>
          <units>smoking quit attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="7.17"/>
                    <measurement group_id="O2" value="1.00" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tele-health Mobile Contingency Management Intervention</title>
          <description>This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.</description>
        </group>
        <group group_id="E2">
          <title>Tele-health for Alcohol and Smoking Cessation</title>
          <description>This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.&#xD;
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings&#xD;
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.&#xD;
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.&#xD;
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization secondary to burned esophagus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization secondary to flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea/diarrhea</sub_title>
                <description>Participants reported nausea or diarrhea as a possible side effect of bupropion</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Increased stress</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Threat of domestic violence</sub_title>
                <description>Participant left home to avoid domestic violence.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Increase in depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <description>Participant reported skin irritation at nicotine patch placement site.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Dental surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Angela Kirby, MS</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>(919) 824-7729</phone>
      <email>angela.kirby@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995915
org study id: Pro00062101
nct id: NCT02995915
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in
      the United States. The purpose of this research study is to develop an intervention designed
      to help people stop drinking alcohol and stop smoking at the same time.
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in
      the United States. Reluctance to treat tobacco dependence among those with AUD is misguided
      as recent research suggests smoking cessation treatment can be effective, does not increase
      risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence
      for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It
      is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals
      misusing substances contingent upon objective evidence from drug use. Implementation of CM
      has been limited because of the need to verify abstinence multiple times daily using clinic
      based monitoring. The investigators recently developed a smart-phone application which allows
      a patient to video themselves several times daily while using a small CO monitor and to
      transmit the data to a secure server which has made the use of CM for outpatient smoking
      cessation portable and feasible. This mobile CM (mCM) approach paired with
      cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective
      in reducing smoking.

      Thus, the purpose of this project is to develop a combined alcohol and smoking mCM
      intervention. The intervention will be developed in two successive cohorts of five
      participants, who will provide information on treatment acceptability and feasibility. A
      third cohort of participants (n=45) will participate in a randomized clinical trials to
      further examine feasibility and efficacy. The long term goal is to develop mCM procedures
      that will be used as part of a multi-component intervention to concurrently and effectively
      treat both alcohol misuse and smoking. As part of this project, the investigators will
      develop a multi-component telehealth alcohol and smoking mCM intervention. It will include
      mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy.
      The work proposed in these aims will provide the first step toward implementation of an
      innovative approach that builds upon the power of mHealth technology to reduce the prevalence
      of both alcohol misuse and smoking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
time frame: 6 month follow-up
description: Participants will be asked to report on smoking since two weeks past quit date
measure: Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified
time frame: 6 month follow-up
description: Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
time frame: 6 month follow-up
description: Participants will be asked to report on alcohol use since two weeks past quit date
measure: Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
time frame: 6 month follow-up
description: Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
measure: Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol
time frame: 6 month follow-up
description: Participants will be asked to report on smoking and alcohol use since two weeks past quit date
measure: Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified
time frame: 6 month follow-up
description: Self-reported prolonged abstinence from smoking will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
time frame: 6 month follow-up
description: 7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
time frame: 6 month follow-up
description: 30-day point prevalence abstinence is defined as no smoking in the prior 30 days
measure: Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use
time frame: 6 month follow-up
description: Participants will self-report number of days drank alcohol in the past 30 days and this will be compared to self-reported number of days drank alcohol in 30 days prior to quit.
measure: Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use
time frame: 6 month follow-up
description: Participants will self-report number of alcoholic beverages consumed in past 7 days and this will be compared to self-reported number of alcoholic beverages consumed in 7 days prior to quit.
measure: Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use
time frame: 6 month follow-up
description: Participants will self-report number of heavy drinking episodes in the past 30 days and this will be compared to self-reported number of heavy drinking episodes in 30 days prior to quit.
measure: Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women)
time frame: 6 month follow-up
description: Participants will be asked to report on alcohol use in past week
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Participants will be asked to report on alcohol use since two weeks past quit date
measure: Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
measure: Change in Number of Average Cigarettes Smoked Per Day
time frame: 6 month follow-up
description: Participants will self-report average number of cigarettes smoked in the past week and this will be compared to self-reported number of smoked in the week prior to quit.
measure: Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use
time frame: 6 month follow-up
description: Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked 30 days prior to quit.
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Participants will be asked to report on smoking since two weeks past quit date
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
description: Participants will be asked to report on smoking since two weeks past quit date
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
description: Participants will be asked to report on alcohol use since two weeks past quit
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Participants will be asked to report on alcohol use since two weeks past quit
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
description: Participants will be asked to report on alcohol use since two weeks past quit
measure: Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Participants will be asked to report on smoking since two weeks past quit date
measure: Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
description: Participants will be asked to report on smoking since two weeks past quit date
measure: Number of Smoking Quit Attempts
time frame: 6 week follow-up (i.e., end of treatment visit)
description: Participants will be asked to report the number of quit attempts made since quit date
measure: Number of Smoking Quit Attempts
time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
description: Participants will be asked to report the number of quit attempts made since quit date
measure: Number of Smoking Quit Attempts
time frame: 6-month follow-up
description: Participants will be asked to report the number of quit attempts made since quit date
arm group label: Tele-health Mobile Contingency Management Intervention
arm group type: Experimental
description: This arm includes a proactive tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, a tele-medicine clinic for access to smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
arm group label: Tele-health for Alcohol and Smoking Cessation
arm group type: Active Comparator
description: This arm includes a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and tele-medicine clinic for access to smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants will receive monetary compensation for each assessment, regardless of abstinence.
intervention type: Other
intervention name: Nicotine Replacement Therapy
description: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
arm group label: Tele-health Mobile Contingency Management Intervention
arm group label: Tele-health for Alcohol and Smoking Cessation
other name: nicotine gum, patch, inhaler, and/or lozenge
intervention type: Drug
intervention name: Bupropion
description: All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
arm group label: Tele-health Mobile Contingency Management Intervention
arm group label: Tele-health for Alcohol and Smoking Cessation
other name: Zyban
intervention type: Behavioral
intervention name: Cognitive Behavioral Treatment
description: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
arm group label: Tele-health Mobile Contingency Management Intervention
arm group label: Tele-health for Alcohol and Smoking Cessation
other name: CBT
intervention type: Behavioral
intervention name: Mobile Contingency Management
description: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
arm group label: Tele-health Mobile Contingency Management Intervention
other name: mobile CM, mCM
intervention type: Behavioral
intervention name: Mobile Monitoring
description: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
arm group label: Tele-health for Alcohol and Smoking Cessation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eric A. Dedert, Ph.D.
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcohol Drinking
mesh term: Bupropion
mesh term: Nicotine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 