<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/NCT02245308</url>
  </required_header>
  <id_info>
    <org_study_id>D1301-R</org_study_id>
    <secondary_id>1828</secondary_id>
    <nct_id>NCT02245308</nct_id>
  </id_info>
  <brief_title>Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers</brief_title>
  <official_title>Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to examine the effects of a treatment for helping homeless&#xD;
      veterans who smoke to stop smoking. Participants in the study will be assigned to one of two&#xD;
      study groups. Participants in the first group will be referred to the local Department of&#xD;
      Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group&#xD;
      participants will receive a behavioral treatment designed to reward smokers for quitting and&#xD;
      staying quit. These participants will also receive telephone counseling and medications for&#xD;
      smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cigarette smoking is the most lethal substance use disorder in the United States in terms of&#xD;
      morbidity and mortality. Veterans who are homeless, along with those who have mental health&#xD;
      or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence&#xD;
      estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at&#xD;
      tremendous risk for smoking related morbidity and mortality. This information suggests that&#xD;
      smoking needs to be targeted specifically among this high risk population of smokers.&#xD;
&#xD;
      The addition of contingency management (CM) to existing evidence-based tele-health smoking&#xD;
      cessation interventions is expected to be a cost-effective way to increase the reach of&#xD;
      intensive smoking cessation treatment. CM is a behavioral therapy that provides positive&#xD;
      reinforcers to individuals misusing substances contingent upon objective evidence of&#xD;
      abstinence from substance use. Because CM requires verification of abstinence multiple times&#xD;
      daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to&#xD;
      inpatient and day treatment programs. The application of emerging smart phone technology,&#xD;
      however, can overcome this barrier, and may be particularly well suited to homeless Veterans.&#xD;
      The innovative smart phone application has made the use of CM for outpatient smoking&#xD;
      cessation portable and feasible. The goal of this comparative effectiveness trial is to&#xD;
      evaluate the effectiveness of a combined tele-health and mobile CM intervention that the&#xD;
      investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose&#xD;
      to screen 165 and randomize 126 homeless Veteran smokers to either:&#xD;
&#xD;
      ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines&#xD;
      guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for&#xD;
      access to smoking cessation aids including choice of pharmacotherapy, and intensive&#xD;
      behavioral therapy through mCM.&#xD;
&#xD;
      VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated&#xD;
      with enrollment in a VA specialty smoking cessation clinic including group counseling,&#xD;
      individual telephone counseling, self-help materials, and smoking cessation aids including&#xD;
      choice of pharmacotherapy.&#xD;
&#xD;
      Specific aims are to:&#xD;
&#xD;
      AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by&#xD;
      bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month&#xD;
      post-randomization follow-ups.&#xD;
&#xD;
      AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted&#xD;
      life years (QALY).&#xD;
&#xD;
      AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.&#xD;
&#xD;
      Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol&#xD;
      abuse) symptoms on treatment outcome across the two conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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 Self-reported and Bioverified Abstinent From Smoking</measure>
    <time_frame>6 months</time_frame>
    <description>Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intervention Delivery Costs</measure>
    <time_frame>6 months</time_frame>
    <description>Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <condition>Homelessness</condition>
  <arm_group>
    <arm_group_label>ART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Patches</intervention_name>
    <description>Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.</description>
    <arm_group_label>ART</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Nicoderm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mobile contingency management (mCM)</intervention_name>
    <description>Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.</description>
    <arm_group_label>ART</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking cessation counseling</intervention_name>
    <description>Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.</description>
    <arm_group_label>ART</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine rescue method</intervention_name>
    <description>Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.</description>
    <arm_group_label>ART</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Nicorette</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.</description>
    <arm_group_label>ART</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Zyban, Wellbutrin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  Homeless&#xD;
&#xD;
          -  Enrolled in Durham VA Medical Center for medical care&#xD;
&#xD;
          -  Current smoker (at least 10 cigarettes per day)&#xD;
&#xD;
          -  Willing to quit smoking in the next 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active substance dependence other than nicotine&#xD;
&#xD;
          -  Uncontrolled psychotic symptoms&#xD;
&#xD;
          -  Severely impaired hearing or speech (must be able to respond to telephone calls)&#xD;
&#xD;
          -  Lack of interest in receiving telephone care&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean C Beckham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durham VA Medical Center, Durham, NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>February 6, 2019</results_first_submitted>
  <results_first_submitted_qc>March 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2019</results_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco use cessation</keyword>
  <keyword>Homelessness</keyword>
  <keyword>Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</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>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT02245308/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Five participants who signed consent were ineligible to participate in the study because they didn't meet basic eligibility criteria. One participant who signed consent was not randomized to treatment because he was unwilling to stop marijuana use prior to participating.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Abstinence Reinforcement Therapy</title>
          <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines:&#xD;
Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.&#xD;
Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.&#xD;
Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.&#xD;
Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63">Using intent-to-treat analyses, i.e., missing=smoking</participants>
                <participants group_id="P2" count="64">Using intent-to-treat analyses, i.e., missing=smoking</participants>
              </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>Abstinence Reinforcement Therapy</title>
          <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines:&#xD;
Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.&#xD;
Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.&#xD;
Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.&#xD;
Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</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="63"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="127"/>
          </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="53.76" spread="10.26"/>
                    <measurement group_id="B2" value="55.72" spread="7.49"/>
                    <measurement group_id="B3" value="54.75" spread="8.99"/>
                  </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="57"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="118"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <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="39"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </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="63"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bioverified abstinent from smoking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Self-reported and Bioverified Abstinent From Smoking</title>
        <description>Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).</description>
        <time_frame>6 months</time_frame>
        <population>All participants who were randomized to treatment were included in the final analysis of bioverified abstinence, using an intent-to-treat sample where missing = smoking</population>
        <group_list>
          <group group_id="O1">
            <title>Abstinence Reinforcement Therapy</title>
            <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines:&#xD;
Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.&#xD;
Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.&#xD;
Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.&#xD;
Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-reported and Bioverified Abstinent From Smoking</title>
          <description>Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).</description>
          <population>All participants who were randomized to treatment were included in the final analysis of bioverified abstinence, using an intent-to-treat sample where missing = 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="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intervention Delivery Costs</title>
        <description>Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abstinence Reinforcement Therapy</title>
            <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines:&#xD;
Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.&#xD;
Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.&#xD;
Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.&#xD;
Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Delivery Costs</title>
          <description>Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.</description>
          <units>dollars</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="618.35" spread="180.02"/>
                    <measurement group_id="O2" value="226.00" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over a one year period.</time_frame>
      <desc>clinicaltrials.gov definitions were used.</desc>
      <group_list>
        <group group_id="E1">
          <title>Abstinence Reinforcement Therapy</title>
          <description>Participants assigned to this treatment arm will receive a tele-health intervention that combines:&#xD;
Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date.&#xD;
Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence.&#xD;
Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.&#xD;
Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.</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="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>High blood pressure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="15" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea or upset stomach</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep difficulties or nightmares</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation or rash</sub_title>
                <description>Due to nicotine patch use</description>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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</name_or_title>
      <organization>Durham VA Health Care System</organization>
      <phone>919-286-0411 ext 175526</phone>
      <email>angela.kirby@va.gov</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/NCT02245308
org study id: D1301-R
secondary id: 1828
nct id: NCT02245308
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this research study is to examine the effects of a treatment for helping homeless
      veterans who smoke to stop smoking. Participants in the study will be assigned to one of two
      study groups. Participants in the first group will be referred to the local Department of
      Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group
      participants will receive a behavioral treatment designed to reward smokers for quitting and
      staying quit. These participants will also receive telephone counseling and medications for
      smoking cessation.
Cigarette smoking is the most lethal substance use disorder in the United States in terms of
      morbidity and mortality. Veterans who are homeless, along with those who have mental health
      or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence
      estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at
      tremendous risk for smoking related morbidity and mortality. This information suggests that
      smoking needs to be targeted specifically among this high risk population of smokers.

      The addition of contingency management (CM) to existing evidence-based tele-health smoking
      cessation interventions is expected to be a cost-effective way to increase the reach of
      intensive smoking cessation treatment. CM is a behavioral therapy that provides positive
      reinforcers to individuals misusing substances contingent upon objective evidence of
      abstinence from substance use. Because CM requires verification of abstinence multiple times
      daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to
      inpatient and day treatment programs. The application of emerging smart phone technology,
      however, can overcome this barrier, and may be particularly well suited to homeless Veterans.
      The innovative smart phone application has made the use of CM for outpatient smoking
      cessation portable and feasible. The goal of this comparative effectiveness trial is to
      evaluate the effectiveness of a combined tele-health and mobile CM intervention that the
      investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose
      to screen 165 and randomize 126 homeless Veteran smokers to either:

      ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines
      guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for
      access to smoking cessation aids including choice of pharmacotherapy, and intensive
      behavioral therapy through mCM.

      VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated
      with enrollment in a VA specialty smoking cessation clinic including group counseling,
      individual telephone counseling, self-help materials, and smoking cessation aids including
      choice of pharmacotherapy.

      Specific aims are to:

      AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by
      bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month
      post-randomization follow-ups.

      AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted
      life years (QALY).

      AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.

      Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol
      abuse) symptoms on treatment outcome across the two conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Self-reported and Bioverified Abstinent From Smoking
time frame: 6 months
description: Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
measure: Intervention Delivery Costs
time frame: 6 months
description: Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
arm group label: ART
arm group type: Experimental
description: Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.
arm group label: Control Group
arm group type: Active Comparator
description: Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
intervention type: Drug
intervention name: Nicotine Patches
description: Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
arm group label: ART
arm group label: Control Group
other name: Nicoderm
intervention type: Behavioral
intervention name: mobile contingency management (mCM)
description: Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
arm group label: ART
intervention type: Behavioral
intervention name: Smoking cessation counseling
description: Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
arm group label: ART
arm group label: Control Group
intervention type: Drug
intervention name: Nicotine rescue method
description: Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
arm group label: ART
arm group label: Control Group
other name: Nicorette
intervention type: Drug
intervention name: Bupropion
description: Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
arm group label: ART
arm group label: Control Group
other name: Zyban, Wellbutrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jean C Beckham, PhD
role: Principal Investigator
affiliation: Durham VA Medical Center, Durham, NC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Bupropion
mesh term: Nicotine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 