<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/NCT01710137</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA033681-01</org_study_id>
    <secondary_id>815435</secondary_id>
    <secondary_id>R01DA033681</secondary_id>
    <nct_id>NCT01710137</nct_id>
  </id_info>
  <brief_title>Varenicline for Nicotine Dependence Among Those With HIV/AIDS</brief_title>
  <official_title>A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral&#xD;
      therapy (HAART) has greatly improved survival rates and changed the leading causes of death,&#xD;
      from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use&#xD;
      among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious&#xD;
      for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310&#xD;
      smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation&#xD;
      counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators&#xD;
      hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment&#xD;
      (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2)&#xD;
      quality of life will be rated higher in the varenicline and counseling group versus the&#xD;
      placebo and counseling group, and there will be no significant differences between treatment&#xD;
      arms in terms of the frequency of severe varenicline-related side effects; and 3) improved&#xD;
      affect and reduced cognitive impairment will mediate the effect of varenicline therapy on&#xD;
      quit rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral&#xD;
      therapy (HAART) has greatly improved survival rates and changed the leading causes of death,&#xD;
      from AIDS-related diseases (e.g., non-Hodgkin's lymphoma, Kaposi sarcoma), to cardiovascular&#xD;
      disease and lung cancer. As such, addressing modifiable risk factors for disease mortality&#xD;
      among those with HIV/AIDS, including tobacco use, has become a critical priority. To date,&#xD;
      only three smoking cessation clinical trials have been conducted with those with HIV/AIDS&#xD;
      none of which investigated the efficacy of FDA-approved medications for nicotine dependence.&#xD;
      Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist with greater efficacy&#xD;
      for treating nicotine dependence than bupropion or nicotine patch. Varenicline may be&#xD;
      particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS&#xD;
      given that depression symptoms and cognitive impairment are common in this population,&#xD;
      increase during smoking abstinence and predict smoking relapse, and are significantly reduced&#xD;
      by varenicline. Therefore, the investigators will conduct a randomized, double-blind,&#xD;
      placebo-controlled trial of varenicline with smokers with HIV/AIDS. Specifically, 310 smokers&#xD;
      with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling&#xD;
      or placebo plus 9 weeks of smoking cessation counseling. The primary outcome variable for&#xD;
      this study will be 7-day biochemically confirmed tobacco abstinence at weeks 12 and 24.&#xD;
      Secondary outcomes include: prolonged abstinence to week 12, 18, and 24 (relapse defined as 7&#xD;
      consecutive days of self-reported smoking, after a 2-week grace period), continuous&#xD;
      abstinence at weeks 12 and 24 (e.g., no smoking between quit day and follow-up), time to&#xD;
      7-day relapse (no grace period), and lapse and recovery events. The trial results may support&#xD;
      the use of varenicline for the treatment of nicotine dependence among those with HIV/AIDS,&#xD;
      thereby reducing tobacco-related morbidity and mortality in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Point Prevalence Tobacco Abstinence</measure>
    <time_frame>Week 12</time_frame>
    <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Point Prevalence Tobacco Abstinence</measure>
    <time_frame>Week 24</time_frame>
    <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous Abstinence to Week 12</measure>
    <time_frame>Weeks 12</time_frame>
    <description>No smoking between the quit day and the follow-up (week 12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous Abstinence to Week 24</measure>
    <time_frame>Weeks 24</time_frame>
    <description>No smoking between the quit day and the follow-up (Week 24).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to 7-day Relapse</measure>
    <time_frame>Week 24</time_frame>
    <description>days to smoking regularly for 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Point Prevalence Tobacco Abstinence</measure>
    <time_frame>Week 18</time_frame>
    <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Varenicline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <arm_group_label>Varenicline</arm_group_label>
    <other_name>Chantix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Counseling</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Varenicline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. 18 years of age or older who self-report smoking at least 5 cigarettes (menthol and&#xD;
             non-menthol) per day, on average.&#xD;
&#xD;
          2. Diagnosed with HIV infection and exhibiting viral load of &lt; 1000 copies/mL and CD4+&#xD;
             counts of &gt; 200 cells/mm3 within 6 months prior to enrollment.&#xD;
&#xD;
          3. Able to use varenicline safely, based on a medical evaluation including medical&#xD;
             history and physical examination, and psychiatric evaluation.&#xD;
&#xD;
          4. Residing in the geographic area for at least 7 months.&#xD;
&#xD;
          5. Women of childbearing potential (based on medical history and physical exam) must&#xD;
             consent to use a medically accepted method of birth control (e.g., condoms and&#xD;
             spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal&#xD;
             ligation) or abstain from sexual intercourse during the time they are taking study&#xD;
             medication and for at least one month after the medication period ends.&#xD;
&#xD;
          6. If current or past diagnosis of bipolar disorder (I, II, or NOS), eligible if:&#xD;
&#xD;
               1. No psychotic features&#xD;
&#xD;
               2. MADRS: total score &lt; 8 (past 4 weeks), suicidal item score &lt; 1 (past 4 weeks)&#xD;
&#xD;
               3. Y-MRS: total score &lt; 8 (past 4 weeks), irritability, speech content, disruptive,&#xD;
                  or aggressive behavior items score &lt; 3 (past 4 weeks)&#xD;
&#xD;
               4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in&#xD;
                  the past 6 months&#xD;
&#xD;
               5. No aggressive or violent acts or behavior in the past 6 months&#xD;
&#xD;
          7. Able to communicate fluently in English.&#xD;
&#xD;
          8. Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the combined consent/HIPAA form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Smoking Behavior&#xD;
&#xD;
          1. Current enrollment or plans to enroll in another smoking cessation program in the next&#xD;
             7 months.&#xD;
&#xD;
          2. Regular (daily) use of chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.&#xD;
&#xD;
          3. Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or&#xD;
             smoking cessation treatments in the next 7 months.&#xD;
&#xD;
               1. Note: Once participants are found eligible for the study, they are told they&#xD;
                  should refrain from using any nicotine replacement therapy (NRT) for the duration&#xD;
                  of the study. If a subject reports an isolated (non-daily) instance of NRT use&#xD;
                  during the study, they may be permitted to continue.&#xD;
&#xD;
        Alcohol/Drug Exclusion Criteria&#xD;
&#xD;
          1. Current untreated and unstable diagnosis of substance abuse or dependence (eligible if&#xD;
             past use and if receiving treatment and stable for &gt;30 days).&#xD;
&#xD;
          2. Positive urine drug screen (for cocaine and/or methamphetamines) at the Intake&#xD;
             Session.&#xD;
&#xD;
          3. Breath Alcohol Concentration (BrAC) assessment greater than or equal to 0.01 at the&#xD;
             Intake Session.&#xD;
&#xD;
        Medication Exclusion Criteria&#xD;
&#xD;
        Current use or recent discontinuation (within last 14 days) of the following medications:&#xD;
&#xD;
          1. Other smoking cessation medications (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix)&#xD;
&#xD;
             a. Note: Once participants are found eligible for the study, they are instructed to&#xD;
             only use the smoking cessation medication provided to them by the study staff. If a&#xD;
             subject reports an isolated (non-daily) instance of using a non-study smoking&#xD;
             cessation medication, the study physician and PI will evaluate the situation and&#xD;
             determine if it is safe for the subject to continue participation.&#xD;
&#xD;
          2. Anti-psychotic medications.&#xD;
&#xD;
        Medical Exclusion Criteria&#xD;
&#xD;
          1. Women who are pregnant, planning a pregnancy within the next 7 months, or lactating.&#xD;
&#xD;
          2. Current diagnosis of unstable and untreated major depression, as determined by&#xD;
             self-report &amp; MINI (eligible if stable for &gt;30 days).&#xD;
&#xD;
          3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI.&#xD;
&#xD;
          4. Any suicide risk score on MINI, current suicidal ideation on Columbia scale, or&#xD;
             self-reported lifetime suicide attempt.&#xD;
&#xD;
          5. History of heart disease, stroke or MI, unstable angina, or tachycardia (if stable,&#xD;
             requires Study Physician approval).&#xD;
&#xD;
          6. Uncontrolled hypertension (SBP &gt;160 or DBP &gt;100).&#xD;
&#xD;
             a. Note: If a participant presents with blood pressure greater than 160/100 at&#xD;
             sessions occurring on Week 0 (Pre-Quit) or at any other point during the treatment&#xD;
             period, they will not be provided with/able to continue on medication unless the study&#xD;
             physician grants approval.&#xD;
&#xD;
          7. History of kidney or liver failure.&#xD;
&#xD;
          8. Abnormal ECG (unless approved by study physician).&#xD;
&#xD;
          9. Estimated creatinine clearance &lt;50 mL/min, within 6 months prior to enrollment.&#xD;
&#xD;
         10. AST and/or ALT results greater than 2 times the upper limit of normal, within 6 months&#xD;
             prior to enrollment.&#xD;
&#xD;
         11. Any impairment (physical, neurological, visual) preventing cognitive task performance.&#xD;
&#xD;
         12. Previous allergic reaction to varenicline.&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Any medical condition or concomitant medication that could compromise subject safety&#xD;
             or treatment, as determined by the Principal Investigator and/or Study Physician.&#xD;
&#xD;
          2. Inability to provide informed consent or complete any of the study tasks as determined&#xD;
             by the Principal Investigator and/or Study Physician.&#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>Robert A Schnoll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>August 14, 2019</results_first_submitted>
  <results_first_submitted_qc>August 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2019</results_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Nicotine dependence</keyword>
  <keyword>Varenicline</keyword>
  <keyword>Chantix</keyword>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varenicline</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT01710137/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Varenicline</title>
          <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Varenicline</title>
          <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</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="89"/>
            <count group_id="B2" value="90"/>
            <count group_id="B3" value="179"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.7" spread="10.1"/>
                    <measurement group_id="B2" value="48.5" spread="9.7"/>
                    <measurement group_id="B3" value="48.6" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="71"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </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="89"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time to First Cigarette (TTFC)</title>
          <description>Time to first cigarette after waking</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Within 5 minutes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6-30 minutes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>31-60 minutes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than 60 minutes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes/Day in Past 7 Days</title>
          <units>Cigarettes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.2" spread="6.6"/>
                    <measurement group_id="B2" value="11.8" spread="9"/>
                    <measurement group_id="B3" value="11.5" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Breath CO</title>
          <units>ppm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" spread="10.4"/>
                    <measurement group_id="B2" value="13.1" spread="7.9"/>
                    <measurement group_id="B3" value="14.1" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Years Smoking</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="10.8"/>
                    <measurement group_id="B2" value="31.1" spread="11"/>
                    <measurement group_id="B3" value="31.5" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Times Quit Smoking for&gt;24 Hours</title>
          <units>number of times quit smoking</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.8" spread="52.9"/>
                    <measurement group_id="B2" value="4.9" spread="12.3"/>
                    <measurement group_id="B3" value="6.9" spread="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Point Prevalence Tobacco Abstinence</title>
        <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Point Prevalence Tobacco Abstinence</title>
          <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Point Prevalence Tobacco Abstinence</title>
        <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
        <time_frame>Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Point Prevalence Tobacco Abstinence</title>
          <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life at Week 12</title>
        <description>The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life at Week 12</title>
          <description>The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.83" spread="4.49"/>
                    <measurement group_id="O2" value="25.95" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Continuous Abstinence to Week 12</title>
        <description>No smoking between the quit day and the follow-up (week 12).</description>
        <time_frame>Weeks 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Continuous Abstinence to Week 12</title>
          <description>No smoking between the quit day and the follow-up (week 12).</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Continuous Abstinence to Week 24</title>
        <description>No smoking between the quit day and the follow-up (Week 24).</description>
        <time_frame>Weeks 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Continuous Abstinence to Week 24</title>
          <description>No smoking between the quit day and the follow-up (Week 24).</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to 7-day Relapse</title>
        <description>days to smoking regularly for 7 days</description>
        <time_frame>Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Time to 7-day Relapse</title>
          <description>days to smoking regularly for 7 days</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.86" spread="73.90"/>
                    <measurement group_id="O2" value="32.48" spread="62.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Point Prevalence Tobacco Abstinence</title>
        <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</description>
        <time_frame>Week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Varenicline</title>
            <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</description>
          </group>
        </group_list>
        <measure>
          <title>Point Prevalence Tobacco Abstinence</title>
          <description>7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.</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="89"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>27 weeks</time_frame>
      <desc>Research staff member completed side effect assessments and determined the severity of the adverse events; the relationship of the event to the study drug and the decision on the course of action for the participant was decided by the site physicians and psychologists after review of the report. Participants were monitored for the development of adverse events by assessing side effects at each assessment time-point, as well as through open-ended questions during assessments.</desc>
      <group_list>
        <group group_id="E1">
          <title>Varenicline</title>
          <description>12 weeks of active varenicline + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Varenicline&#xD;
Smoking Cessation Counseling</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>12 weeks of placebo + smoking cessation counseling&#xD;
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally&#xD;
Placebo&#xD;
Smoking Cessation Counseling</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="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer metastasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Cancer diagnosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidality</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </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="19" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>ER visit</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="89"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="89"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="90"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin redness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="90"/>
              </event>
              <event>
                <sub_title>Skin swelling</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="89"/>
                <counts group_id="E2" events="28" subjects_affected="28" subjects_at_risk="90"/>
              </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. Robert Schnoll</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-746-7143</phone>
      <email>schnoll@pennmedicine.upenn.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/NCT01710137
org study id: R01DA033681-01
secondary id: 815435
secondary id: R01DA033681
nct id: NCT01710137
lead sponsor: 
collaborator: 
has dmc: Yes
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral
      therapy (HAART) has greatly improved survival rates and changed the leading causes of death,
      from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use
      among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious
      for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310
      smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation
      counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators
      hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment
      (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2)
      quality of life will be rated higher in the varenicline and counseling group versus the
      placebo and counseling group, and there will be no significant differences between treatment
      arms in terms of the frequency of severe varenicline-related side effects; and 3) improved
      affect and reduced cognitive impairment will mediate the effect of varenicline therapy on
      quit rates.
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral
      therapy (HAART) has greatly improved survival rates and changed the leading causes of death,
      from AIDS-related diseases (e.g., non-Hodgkin's lymphoma, Kaposi sarcoma), to cardiovascular
      disease and lung cancer. As such, addressing modifiable risk factors for disease mortality
      among those with HIV/AIDS, including tobacco use, has become a critical priority. To date,
      only three smoking cessation clinical trials have been conducted with those with HIV/AIDS
      none of which investigated the efficacy of FDA-approved medications for nicotine dependence.
      Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist with greater efficacy
      for treating nicotine dependence than bupropion or nicotine patch. Varenicline may be
      particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS
      given that depression symptoms and cognitive impairment are common in this population,
      increase during smoking abstinence and predict smoking relapse, and are significantly reduced
      by varenicline. Therefore, the investigators will conduct a randomized, double-blind,
      placebo-controlled trial of varenicline with smokers with HIV/AIDS. Specifically, 310 smokers
      with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling
      or placebo plus 9 weeks of smoking cessation counseling. The primary outcome variable for
      this study will be 7-day biochemically confirmed tobacco abstinence at weeks 12 and 24.
      Secondary outcomes include: prolonged abstinence to week 12, 18, and 24 (relapse defined as 7
      consecutive days of self-reported smoking, after a 2-week grace period), continuous
      abstinence at weeks 12 and 24 (e.g., no smoking between quit day and follow-up), time to
      7-day relapse (no grace period), and lapse and recovery events. The trial results may support
      the use of varenicline for the treatment of nicotine dependence among those with HIV/AIDS,
      thereby reducing tobacco-related morbidity and mortality in this population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Point Prevalence Tobacco Abstinence
time frame: Week 12
description: 7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
measure: Point Prevalence Tobacco Abstinence
time frame: Week 24
description: 7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
measure: Quality of Life at Week 12
time frame: Week 12
description: The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.
measure: Continuous Abstinence to Week 12
time frame: Weeks 12
description: No smoking between the quit day and the follow-up (week 12).
measure: Continuous Abstinence to Week 24
time frame: Weeks 24
description: No smoking between the quit day and the follow-up (Week 24).
measure: Time to 7-day Relapse
time frame: Week 24
description: days to smoking regularly for 7 days
measure: Point Prevalence Tobacco Abstinence
time frame: Week 18
description: 7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
arm group label: Varenicline
arm group type: Active Comparator
description: 12 weeks of active varenicline + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
arm group label: Placebo
arm group type: Placebo Comparator
description: 12 weeks of placebo + smoking cessation counseling
Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
intervention type: Drug
intervention name: Varenicline
arm group label: Varenicline
other name: Chantix
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Behavioral
intervention name: Smoking Cessation Counseling
arm group label: Placebo
arm group label: Varenicline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert A Schnoll, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Varenicline
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 