<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/NCT03276780</url>
  </required_header>
  <id_info>
    <org_study_id>F151019004</org_study_id>
    <nct_id>NCT03276780</nct_id>
  </id_info>
  <brief_title>Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence</brief_title>
  <acronym>NRT</acronym>
  <official_title>NRT Sampling and Selection to Increase Medication Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and&#xD;
      examine the underlying mechanisms of action associated with adherence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adherence is a critical target for successful smoking cessation, with good adherence&#xD;
      associated with a three-fold increase in cessation rates relative to poor adherence.&#xD;
      Psychoeducational interventions focused on increasing adherence to NRT do not result in&#xD;
      behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with&#xD;
      practice quit attempts (PQAs), are based on learning theory models of behavioral change and&#xD;
      have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to&#xD;
      psychoeducation or motivational interventions. However, nicotine sampling still relies of the&#xD;
      participant using NRT outside of session, which may not occur. Providing an experiential&#xD;
      intervention in which the NRT is sampled and any problems with NRT reframed during the&#xD;
      session may provide a powerful learning experience that can increase in home sampling with&#xD;
      PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This&#xD;
      may be particularly relevant for low-income smokers who hold more negative views of NRT, have&#xD;
      lower health literacy, and are less likely to use medication during cessation attempts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Single Group Assignment</intervention_model>
    <intervention_model_description>In vivo or standard of care</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Participant Retention</measure>
    <time_frame>From baseline through 4 months</time_frame>
    <description>Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Recruitment</measure>
    <time_frame>56 weeks</time_frame>
    <description>The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Enrollment</measure>
    <time_frame>56 weeks</time_frame>
    <description>The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>5 weeks</time_frame>
    <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>13 weeks</time_frame>
    <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>4 months</time_frame>
    <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Expectancies at Baseline</measure>
    <time_frame>Assessed at baseline</time_frame>
    <description>Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Credibility</measure>
    <time_frame>5 weeks</time_frame>
    <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Credibility</measure>
    <time_frame>13 weeks</time_frame>
    <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Credibility</measure>
    <time_frame>4 months</time_frame>
    <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Medication Adherence at Week 6</measure>
    <time_frame>From baseline through 6 weeks</time_frame>
    <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Medication Adherence at Week 9</measure>
    <time_frame>From baseline through 9 weeks</time_frame>
    <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Medication Adherence at Week 13</measure>
    <time_frame>From baseline through 13 weeks</time_frame>
    <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>In vivo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling</intervention_name>
    <description>Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking</description>
    <arm_group_label>In vivo</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>combination NRT</intervention_name>
    <description>Both groups will receive combination NRT to help with smoking cessation</description>
    <arm_group_label>In vivo</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        a) 18 years or older; b) qualifying as low income (as defined by making &lt;150% above the&#xD;
        poverty line or &lt;$22,260 as a single or &lt;$45,570 for a family of four); c) Smoking at least&#xD;
        5 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than&#xD;
        8 ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation&#xD;
        of enrolling a large &gt;50% African-American who average &lt;10 CPD compared to Whites who&#xD;
        average ~15 CPD.; and d) English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or&#xD;
        nursing (all women will be required to use an acceptable form of contraception); c)&#xD;
        Currently enrolled in a smoking cessation treatment program, using NRT products, or&#xD;
        prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement&#xD;
        products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a&#xD;
        pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or&#xD;
        untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such&#xD;
        as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition&#xD;
        that interferes with the informed consent process (individuals stable on psychiatric&#xD;
        medications will be included); or i) Daily or exclusive use of other tobacco products&#xD;
        (e.g., electronic cigarettes, little cigars, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Cropsey, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</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 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>September 1, 2021</results_first_submitted>
  <results_first_submitted_qc>December 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2021</results_first_posted>
  <last_update_submitted>December 17, 2021</last_update_submitted>
  <last_update_submitted_qc>December 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Karen Cropsey</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03276780/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03276780/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>In Vivo</title>
          <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved out of state</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Already enrolled in another smoking cessation study providing NRT</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No show to appointments after baseline through Week 5</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>In Vivo</title>
          <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</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="41"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <description>Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race.</description>
          <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="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="78"/>
                  </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>
          <description>Demographic information was collected using the Demographic Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used to collect demographic information about the participant, including age, sex, ethnicity, and race.</description>
          <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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quitting Smoking Behaviors at Baseline</title>
          <description>Quitting smoking behaviors was measured using the Smoking History Form, a measure developed in the research lab (i.e. no standardized scoring). This measure was used as a demographic form to collect information about participant history of smoking behaviors and quitting smoking behaviors.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thinking of quitting smoking in the next month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thinking of quitting smoking within the next 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried NRT to help quit smoking before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried therapy to help quit smoking before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried self-help materials to help quit before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried hypnosis to help quit smoking before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried medication to help quit smoking before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tried e-cigarettes to help quit smoking before?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Are any medical problems worsened by smoking?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Live with people who smoke?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not thinking of quitting smoking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes Per Day at Baseline</title>
          <units>cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.46" spread="11.05"/>
                    <measurement group_id="B2" value="18.36" spread="9.26"/>
                    <measurement group_id="B3" value="18.93" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Carbon Monoxide (CO) Level at Baseline</title>
          <units>parts per million (ppm) of CO</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.56" spread="11.28"/>
                    <measurement group_id="B2" value="18.23" spread="8.02"/>
                    <measurement group_id="B3" value="18.40" spread="9.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Years Smoked Reported at Baseline</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.73" spread="11.18"/>
                    <measurement group_id="B2" value="28.92" spread="10.82"/>
                    <measurement group_id="B3" value="26.79" spread="11.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intensity of Nicotine Dependency at Baseline</title>
          <description>Fagerstrom Test for Nicotine Dependence (FTND) is a standardized instrument for assessing the intensity of physical addiction to nicotine. The FTND contains six items containing yes/no items and multiple choice items. Yes/no items are scored from 0 to 1, and the multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0 to 10. The lowest score on the FTND is a 0, and the highest score on the FTND is a 10. The higher the total FTND score, the worse the participants' outcome is since this indicates a greater intensity of physical dependency on nicotine.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.49" spread="1.79"/>
                    <measurement group_id="B2" value="6.0" spread="1.84"/>
                    <measurement group_id="B3" value="6.26" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Urges at Baseline</title>
          <description>Participant smoking urges were assessed using the Questionnaire of Smoking Urges (QSU), which is a standardized assessment used to determine level of cravings for smoking. There are ten items in this assessment, and each item was rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The items are summed to determine a total score for level of smoking urges. The lowest score on this scale is 10, and the highest score on the scale is 70. Higher scores indicate worse outcomes for the participant since higher scores indicate more intense smoking urges.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.07" spread="15.54"/>
                    <measurement group_id="B2" value="44.36" spread="16.58"/>
                    <measurement group_id="B3" value="45.24" spread="15.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Participant Retention</title>
        <description>Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.</description>
        <time_frame>From baseline through 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Participant Retention</title>
          <description>Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.</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="41"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participant retention rate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participant attrition rate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Recruitment</title>
        <description>The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
        <time_frame>56 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Participants Screened</title>
            <description>The total number of participants who were screened for potential enrollment in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Recruitment</title>
          <description>The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
          <units>participants screened per week</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="327"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Enrollment</title>
        <description>The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
        <time_frame>56 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Total Participants Enrolled</title>
            <description>The total number of participants enrolled in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Enrollment</title>
          <description>The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.</description>
          <units>participants enrolled per week</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Satisfaction</title>
        <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
        <time_frame>5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction</title>
          <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.70" spread="3.81"/>
                    <measurement group_id="O2" value="69.20" spread="4.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Satisfaction</title>
        <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction</title>
          <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.21" spread="10.67"/>
                    <measurement group_id="O2" value="66.39" spread="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Satisfaction</title>
        <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
        <time_frame>4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Satisfaction</title>
          <description>Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.35" spread="9.82"/>
                    <measurement group_id="O2" value="65.62" spread="10.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Expectancies at Baseline</title>
        <description>Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.</description>
        <time_frame>Assessed at baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Expectancies at Baseline</title>
          <description>Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.29" spread="7.68"/>
                    <measurement group_id="O2" value="21.23" spread="10.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Credibility</title>
        <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
        <time_frame>5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Credibility</title>
          <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="3.67"/>
                    <measurement group_id="O2" value="0.84" spread="5.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Credibility</title>
        <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
        <time_frame>13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Credibility</title>
          <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" spread="5.12"/>
                    <measurement group_id="O2" value="0.08" spread="3.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Treatment Credibility</title>
        <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
        <time_frame>4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Credibility</title>
          <description>Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="5.22"/>
                    <measurement group_id="O2" value="-1.64" spread="5.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Medication Adherence at Week 6</title>
        <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
        <time_frame>From baseline through 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medication Adherence at Week 6</title>
          <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</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="26"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No patch doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No NRT doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Medication Adherence at Week 9</title>
        <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
        <time_frame>From baseline through 9 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medication Adherence at Week 9</title>
          <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</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="26"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No patch doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No NRT doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Medication Adherence at Week 13</title>
        <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</description>
        <time_frame>From baseline through 13 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Vivo</title>
            <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medication Adherence at Week 13</title>
          <description>Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.</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="21"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No patch doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No NRT doses missed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through 4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>In Vivo</title>
          <description>Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.&#xD;
Counseling: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking&#xD;
combination NRT: Both groups will receive combination NRT to help with smoking cessation</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Undisclosed Virus</sub_title>
                <description>Participant reported being hospitalized to be treated for an undisclosed virus between sessions.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Severe Depression</sub_title>
                <description>Participant was admitted to inpatient psychiatric treatment for symptoms of depression between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>Participant was hospitalized for treatment for pneumonia between baseline and the first intervention session. Participant was unable to complete the first intervention session for 3 weeks.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="41"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <description>Occurred while using the nicotine nasal spray. 1 instance occurred without any NRT use (not related to study medication).</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Watering Eyes</sub_title>
                <description>Occurred when using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach ache</sub_title>
                <description>Occurred when using the nicotine patches and nicotine lozenges in combination.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Occurred after using the nicotine patch, nicotine inhaler, nicotine gum, and nicotine lozenges.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Occurred when using the nicotine replacement products.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nicotine Dosage Too Strong</sub_title>
                <description>Occurred while using the nicotine gum.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Vivid Dreams/Nightmares</sub_title>
                <description>Occurred while using either the 21 mg patch or 14 mg patch.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Occurred when using the nicotine patches and nicotine lozenges in combination, as well as when using the nicotine inhaler.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Jitteriness</sub_title>
                <description>Occurred when using the nicotine inhaler.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Increased Heart Rate</sub_title>
                <description>Occurred when using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Tooth Pain</sub_title>
                <description>Participant reported tooth pain during session that was not related to using the study NRT medication.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Irritation</sub_title>
                <description>Occurred while using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <description>Occurred while using the nicotine nasal spray.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nasal Drainage</sub_title>
                <description>Occurred while using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Excessive Sneezing</sub_title>
                <description>Occurred while using the nicotine nasal spray.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Burning Mouth/Throat</sub_title>
                <description>Occurred while using the 2 mg or 4 mg nicotine lozenges/gum or the nicotine inhaler</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Excessive Coughing</sub_title>
                <description>Occurred when using the nicotine inhaler.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nasal Burning</sub_title>
                <description>Occurred when using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nasal Tingling</sub_title>
                <description>Occurred when using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nasal Blistering</sub_title>
                <description>Occurred when using the nicotine nasal spray.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <description>A participant reported being treated for an upper respiratory infection. This infection was unrelated to the participant using any study NRT medication.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <description>Occurred while using the 21 mg or 14 mg nicotine patch. 1 participant reported an unrelated neck rash while using the 4 mg and 2 mg nicotine lozenges.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </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>Dr. Karen Cropsey</name_or_title>
      <organization>University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology</organization>
      <phone>205-975-4204</phone>
      <email>kcropsey@uabmc.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/NCT03276780
org study id: F151019004
nct id: NCT03276780
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and
      examine the underlying mechanisms of action associated with adherence.
Adherence is a critical target for successful smoking cessation, with good adherence
      associated with a three-fold increase in cessation rates relative to poor adherence.
      Psychoeducational interventions focused on increasing adherence to NRT do not result in
      behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with
      practice quit attempts (PQAs), are based on learning theory models of behavioral change and
      have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to
      psychoeducation or motivational interventions. However, nicotine sampling still relies of the
      participant using NRT outside of session, which may not occur. Providing an experiential
      intervention in which the NRT is sampled and any problems with NRT reframed during the
      session may provide a powerful learning experience that can increase in home sampling with
      PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This
      may be particularly relevant for low-income smokers who hold more negative views of NRT, have
      lower health literacy, and are less likely to use medication during cessation attempts.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: In vivo or standard of care
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Participant Retention
time frame: From baseline through 4 months
description: Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.
measure: Rate of Recruitment
time frame: 56 weeks
description: The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.
measure: Rate of Enrollment
time frame: 56 weeks
description: The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.
measure: Treatment Satisfaction
time frame: 5 weeks
description: Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
measure: Treatment Satisfaction
time frame: 13 weeks
description: Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
measure: Treatment Satisfaction
time frame: 4 months
description: Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.
measure: Treatment Expectancies at Baseline
time frame: Assessed at baseline
description: Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.
measure: Treatment Credibility
time frame: 5 weeks
description: Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
measure: Treatment Credibility
time frame: 13 weeks
description: Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
measure: Treatment Credibility
time frame: 4 months
description: Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.
measure: Number of Participants With Medication Adherence at Week 6
time frame: From baseline through 6 weeks
description: Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
measure: Number of Participants With Medication Adherence at Week 9
time frame: From baseline through 9 weeks
description: Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
measure: Number of Participants With Medication Adherence at Week 13
time frame: From baseline through 13 weeks
description: Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.
arm group label: In vivo
arm group type: Experimental
description: Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
arm group label: Standard of care
arm group type: Active Comparator
description: Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
intervention type: Behavioral
intervention name: Counseling
description: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
arm group label: In vivo
arm group label: Standard of care
intervention type: Drug
intervention name: combination NRT
description: Both groups will receive combination NRT to help with smoking cessation
arm group label: In vivo
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Cropsey, PsyD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Karen Cropsey
investigator title: Professor of Psychiatry
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 