<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/NCT01679236</url>
  </required_header>
  <id_info>
    <org_study_id>H-2006-0279</org_study_id>
    <secondary_id>P50DA019706-09</secondary_id>
    <nct_id>NCT01679236</nct_id>
  </id_info>
  <brief_title>Pilot Study on Mindfulness for Tobacco and Alcohol in University Students</brief_title>
  <official_title>Pilot Study on Mindfulness for Tobacco and Alcohol in University Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</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 Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A. The study follows a randomized controlled design with approximately 60 smokers with a&#xD;
      history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention&#xD;
      to a matched 7-week education intervention to evaluate intervention effect on smoking&#xD;
      cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness&#xD;
      intervention will yield statistically significantly higher smoking abstinence than controls&#xD;
      as measured by carbon monoxide breath test and Time Line Follow Back at at the end of&#xD;
      treatment (2-weeks post smoking cessation attempt).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      B. The study follows a randomized controlled study design with division of approximately 60&#xD;
      individuals into 2 groups. The study group (n=30) will be called &quot;Mindfulness Training for&#xD;
      Smokers&quot; (MTS) and will provide 7 weeks of mindfulness meditation instruction. The control&#xD;
      group (n=30) will be called the &quot;Interactive Learning for Smokers&quot; (ILS) will provide 7 weeks&#xD;
      of addiction instruction. Classes in both groups will be 2 hours long. At meeting 5, the&#xD;
      &quot;quit day,&quot; all participants will attempt to quit smoking permanently and attempt to quit&#xD;
      using alcohol for 4 weeks.&#xD;
&#xD;
      Mindfulness Training For Smokers (MTS) Course Outline is as following:&#xD;
&#xD;
      Meeting 1 Introduction. Meditation training: posture, breath counting, mindful recognition of&#xD;
      thoughts. Mindfulness meditation: physical sensation, emotion. Philosophical orientation:&#xD;
      addiction, meditation. Meeting 2 Mindful monitoring: craving curve, withdrawal symptoms&#xD;
      (agitation, anxiousness, anger, anhedonia, confusion, hunger, defeatist thoughts). Meeting 3&#xD;
      Education: tobacco and alcohol disorders. Motivational information. Meeting 4 Practical&#xD;
      strategies: tobacco and alcohol cessation. Meeting 5 QUIT DAY, Individual-work and group-work&#xD;
      focusing on thoughts, cravings, and withdrawal symptoms occurring in individuals that day.&#xD;
      Meeting 6 Individual and group discussion of progress. Review: mindfulness, thoughts,&#xD;
      emotions, physical sensations, drug cues, triggers. Meeting 7 Discussion of long-term&#xD;
      meditation practices and risks.&#xD;
&#xD;
      Daily Mindfulness Meditation: All participants will be asked to meditate 30 minutes per day&#xD;
      for 7 weeks.&#xD;
&#xD;
      Control Group Intervention (ILS) The control intervention is designed to be a time matched&#xD;
      effective treatment for tobacco and alcohol addiction. The treatment is an interactive&#xD;
      &quot;class&quot; in addiction including 7 meetings (matched to study subjects). Controls will be asked&#xD;
      to engage in daily &quot;non-directed walking&quot; 30 minutes per day and not smoking when they walk.&#xD;
      In addition, controls (as study group participants) will be provided with other practical&#xD;
      strategies for smoking cessation taken from the American Lung Association, Freedom from&#xD;
      Smoking program and The Mayo Clinic Nicotine Dependence Center program.&#xD;
&#xD;
      Quit day: The quit day for controls as well as study subjects will be at meeting-5 (same as&#xD;
      for study group). For study subjects, this day will be held in silence and will include 5&#xD;
      hours of various meditation practices, including a silent bag lunch. For controls, this day&#xD;
      will include a 5-hour study session in a punctuated by several non-directed walks. All class&#xD;
      time activities and quit day activities will be conducted as a group. MTS and ILS study&#xD;
      participants will attempt smoking cessation at midnight the night before meeting five.&#xD;
      Participants will be told to collect and destroy all of their alcohol, cigarettes, and&#xD;
      tobacco-related paraphernalia beforehand. During the meeting on the &quot;quit day&quot; participants&#xD;
      will perform CO testing to confirm abstinence. A secondary goal of the intervention is&#xD;
      alcohol reduction for the purpose of reducing risk for smoking relapse. Because long term&#xD;
      complete abstinence from alcohol is an unnecessary and perhaps unrealistic, goal for most&#xD;
      non-dependent drinkers, the goal for all participants is alcohol abstinence for 4 weeks.&#xD;
&#xD;
      Description of Sample: Participants will consist of 60 subjects age 18-25. There will be an&#xD;
      effort to include gender and ethnicity with distribution seen in the Madison population.&#xD;
&#xD;
      C. Recruitment: Recruitment will be conducted through placement of recruitment flyers&#xD;
      throughout the UW-Madison, MATC, and Edgewood campuses as well as the greater Madison area.&#xD;
      Recruitment will also use recruitment flyer in electronic form to advertise and through&#xD;
      Craig's List and newspaper ads. These will all use identical format as is used in the flyer.&#xD;
      For each of these mediums, an electronic version of the recruitment flyer will be posted.&#xD;
      Recruitment will also included one-minute presentations to classes by personnel or the&#xD;
      faculty/staff teaching the class. This will entail showing a power point slide with the&#xD;
      electronic recruitment flyer, and may or may not include reading it out loud to students.&#xD;
      This will only occur if the professor of a particular class agrees to this one minute&#xD;
      presentation. Advertisements will state that the intervention is designed to help&#xD;
      participants quit smoking. An effort will also be made to include minority students in a&#xD;
      percentage that reflects university minority enrollment. Respondents will be screened by&#xD;
      phone for the criteria listed below. Those who meet criteria will be scheduled for an&#xD;
      orientation session, which will describe the intervention. Interested individuals will be&#xD;
      offered the consent form, after which, randomization to study group or control group will be&#xD;
      performed via random number generation. Recruitment will continue until 30 controls and 30&#xD;
      group participants (3 cohorts of 10) have been enrolled or until statistical significance&#xD;
      between groups is reached. Subjects will be paid $20 at the quit day, the 2 week post-quit&#xD;
      visit, and $40 at the 8-week and 6-month post-quit visits (total of $120). In addition to a&#xD;
      total of $120 per participant payment, participants who come to all 4 data collection days&#xD;
      will have their name put in a &quot;lottery&quot; drawing for $1000.&#xD;
&#xD;
      Inclusions: 1) Age 18 to 29 years; 2) Tobacco use of at least 10 cigarettes per day for at&#xD;
      least 6 months; and, 3) Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for a&#xD;
      male, 4 or more for a female). Rationale for Inclusions: Tobacco use levels are set to allow&#xD;
      for a broad range of daily tobacco use, while eliminating occasional smokers. Alcohol use set&#xD;
      at this level to include the majority of student smokers (known to drink at this level) and&#xD;
      provide outcomes information on co-treatment of alcohol and tobacco.&#xD;
&#xD;
      Exclusions: 1) A baseline (orientation meeting) CO level &lt; 10, 2) Self report of pre-existing&#xD;
      diagnosis of bipolar disorder, schizophrenia or other delusional disorder; 3) Self report of&#xD;
      pre-existing diagnosis of personality disorder (e.g., borderline, antisocial, schizoaffective&#xD;
      personality disorders). 4) Self report of alcohol use of 4 drinks or more a night on 6 or&#xD;
      more nights per week.&#xD;
&#xD;
      Rationale for Exclusions: Bipolar disorder, Schizophrenia, delusional disorders, and&#xD;
      personality disorders are used as exclusions because of the high potential for individuals&#xD;
      with these disorders to disrupt other participants in therapeutic group session. A CO level&#xD;
      of 10 is required to establish a minimal level of tobacco dependence. High level alcohol use&#xD;
      is an exclusion criterion because these individuals may withdraw from alcohol during alcohol&#xD;
      reduction.&#xD;
&#xD;
      Hypothesis: The primary hypothesis is that the mindfulness intervention will yield&#xD;
      statistically significantly higher smoking abstinence than controls as measured by carbon&#xD;
      monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post&#xD;
      smoking cessation attempt).&#xD;
&#xD;
      D. Safety Monitoring Plan This study proposes to obtain information from participants about&#xD;
      their age, race, gender, as well as psychiatric and drug use information. All data from human&#xD;
      subjects in this research protocol will be obtained by interview or questionnaire and will be&#xD;
      obtained specifically for research purposes. Subject names will not be kept on data records,&#xD;
      but instead, a standardized code will be used for identification. Access to these code&#xD;
      numbers will be limited to staff members of the research team. All collected forms will be&#xD;
      stored in locked file cabinets. Patient identifiers will be kept in separate files from the&#xD;
      data forms. All patient identifiers will be destroyed at the end of the trial. No existing&#xD;
      records or data will be utilized. Alcohol Withdrawal: Symptoms of alcohol withdrawal in&#xD;
      clinically dependent drinkers include sweating, nervousness, nausea and vomiting, headaches,&#xD;
      myalgias, tremors, delusions, hallucinations, seizures and death. Heavy drinkers (4 or more&#xD;
      drinks/day) will be excluded from the study to ensure that subjects with a potential for&#xD;
      clinical withdrawal are not in the study. Nonetheless, participants will be instructed that&#xD;
      if symptoms of withdrawal occur, they are to report immediately to the emergency room for&#xD;
      treatment and notify Dr. Davis (PI) of their condition. Dr. Davis is board certified in&#xD;
      Internal Medicine and routinely manages patients in alcohol withdrawal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">September 2009</completion_date>
  <primary_completion_date type="Actual">September 2007</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Abstinence</measure>
    <time_frame>2 weeks post quit day</time_frame>
    <description>Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use in Study Subjects vs Controls</measure>
    <time_frame>2 weeks post quit day</time_frame>
    <description>Timeline follow back participant self-report of daily alcohol use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Nicotine Dependence</condition>
  <condition>Alcohol Use</condition>
  <arm_group>
    <arm_group_label>Mindfulness Training for Smokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interactive Learning for Smokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Training for Smokers</intervention_name>
    <description>The provides the Mindfulness Training for Smokers intervention (7 weeks long).</description>
    <arm_group_label>Mindfulness Training for Smokers</arm_group_label>
    <other_name>Study Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interactive Learning for Smokers</intervention_name>
    <description>This provides the Interactive Learning for Smokers intervention (7 weeks long).</description>
    <arm_group_label>Interactive Learning for Smokers</arm_group_label>
    <other_name>Control Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18 to 29 years&#xD;
&#xD;
          2. Tobacco use of at least 10 cigarettes per day for at least 6 months&#xD;
&#xD;
          3. Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for males, 4 or more&#xD;
             for females)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Baseline (orientation meeting) CO level &lt; 10&#xD;
&#xD;
          2. Self report of pre-existing bipolar disorder, schizophrenia, other delusional disorder&#xD;
&#xD;
          3. Self report of pre-existing diagnosis of personality disorder (e.g. borderline,&#xD;
             antisocial, schizoaffective personality disorders)&#xD;
&#xD;
          4. Self report of alcohol use of 4 drinks or more on 6 or more nights per week.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James M Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>May 19, 2014</results_first_submitted>
  <results_first_submitted_qc>May 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 24, 2014</results_first_posted>
  <last_update_submitted>May 19, 2014</last_update_submitted>
  <last_update_submitted_qc>May 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>Nicotine</keyword>
  <keyword>Tobacco</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Meditation</keyword>
  <keyword>MBSR</keyword>
  <keyword>Mindfulness Training</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Alcohol</keyword>
  <keyword>Young Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness Training for Smokers</title>
          <description>Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.&#xD;
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).</description>
        </group>
        <group group_id="P2">
          <title>Interactive Learning for Smokers</title>
          <description>Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.&#xD;
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Total randomized</population>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness Training for Smokers</title>
          <description>Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.&#xD;
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).</description>
        </group>
        <group group_id="B2">
          <title>Interactive Learning for Smokers</title>
          <description>Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.&#xD;
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="55"/>
          </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="21.7" spread="2.42"/>
                    <measurement group_id="B2" value="22.2" spread="2.68"/>
                    <measurement group_id="B3" value="21.93" spread="2.53"/>
                  </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="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </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="30"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Smoking Abstinence</title>
        <description>Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day</description>
        <time_frame>2 weeks post quit day</time_frame>
        <population>total enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Training for Smokers</title>
            <description>Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.&#xD;
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).</description>
          </group>
          <group group_id="O2">
            <title>Interactive Learning for Smokers</title>
            <description>Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.&#xD;
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Abstinence</title>
          <description>Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day</description>
          <population>total enrolled</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Use in Study Subjects vs Controls</title>
        <description>Timeline follow back participant self-report of daily alcohol use.</description>
        <time_frame>2 weeks post quit day</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness Training for Smokers</title>
          <description>Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.&#xD;
Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long).</description>
        </group>
        <group group_id="E2">
          <title>Interactive Learning for Smokers</title>
          <description>Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.&#xD;
Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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>
    <limitations_and_caveats>Participants were not blinded to their respective treatment conditions.&#xD;
Attrition reduced power and generalizability.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>James M. Davis MD, Assistant Professor, Duke University</name_or_title>
      <organization>University of Wisconsin</organization>
      <phone>608-217-9405</phone>
      <email>jjamesdavis@hotmail.com</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/NCT01679236
org study id: H-2006-0279
secondary id: P50DA019706-09
nct id: NCT01679236
lead sponsor: 
collaborator: 
has dmc: Yes
A. The study follows a randomized controlled design with approximately 60 smokers with a
      history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention
      to a matched 7-week education intervention to evaluate intervention effect on smoking
      cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness
      intervention will yield statistically significantly higher smoking abstinence than controls
      as measured by carbon monoxide breath test and Time Line Follow Back at at the end of
      treatment (2-weeks post smoking cessation attempt).
B. The study follows a randomized controlled study design with division of approximately 60
      individuals into 2 groups. The study group (n=30) will be called "Mindfulness Training for
      Smokers" (MTS) and will provide 7 weeks of mindfulness meditation instruction. The control
      group (n=30) will be called the "Interactive Learning for Smokers" (ILS) will provide 7 weeks
      of addiction instruction. Classes in both groups will be 2 hours long. At meeting 5, the
      "quit day," all participants will attempt to quit smoking permanently and attempt to quit
      using alcohol for 4 weeks.

      Mindfulness Training For Smokers (MTS) Course Outline is as following:

      Meeting 1 Introduction. Meditation training: posture, breath counting, mindful recognition of
      thoughts. Mindfulness meditation: physical sensation, emotion. Philosophical orientation:
      addiction, meditation. Meeting 2 Mindful monitoring: craving curve, withdrawal symptoms
      (agitation, anxiousness, anger, anhedonia, confusion, hunger, defeatist thoughts). Meeting 3
      Education: tobacco and alcohol disorders. Motivational information. Meeting 4 Practical
      strategies: tobacco and alcohol cessation. Meeting 5 QUIT DAY, Individual-work and group-work
      focusing on thoughts, cravings, and withdrawal symptoms occurring in individuals that day.
      Meeting 6 Individual and group discussion of progress. Review: mindfulness, thoughts,
      emotions, physical sensations, drug cues, triggers. Meeting 7 Discussion of long-term
      meditation practices and risks.

      Daily Mindfulness Meditation: All participants will be asked to meditate 30 minutes per day
      for 7 weeks.

      Control Group Intervention (ILS) The control intervention is designed to be a time matched
      effective treatment for tobacco and alcohol addiction. The treatment is an interactive
      "class" in addiction including 7 meetings (matched to study subjects). Controls will be asked
      to engage in daily "non-directed walking" 30 minutes per day and not smoking when they walk.
      In addition, controls (as study group participants) will be provided with other practical
      strategies for smoking cessation taken from the American Lung Association, Freedom from
      Smoking program and The Mayo Clinic Nicotine Dependence Center program.

      Quit day: The quit day for controls as well as study subjects will be at meeting-5 (same as
      for study group). For study subjects, this day will be held in silence and will include 5
      hours of various meditation practices, including a silent bag lunch. For controls, this day
      will include a 5-hour study session in a punctuated by several non-directed walks. All class
      time activities and quit day activities will be conducted as a group. MTS and ILS study
      participants will attempt smoking cessation at midnight the night before meeting five.
      Participants will be told to collect and destroy all of their alcohol, cigarettes, and
      tobacco-related paraphernalia beforehand. During the meeting on the "quit day" participants
      will perform CO testing to confirm abstinence. A secondary goal of the intervention is
      alcohol reduction for the purpose of reducing risk for smoking relapse. Because long term
      complete abstinence from alcohol is an unnecessary and perhaps unrealistic, goal for most
      non-dependent drinkers, the goal for all participants is alcohol abstinence for 4 weeks.

      Description of Sample: Participants will consist of 60 subjects age 18-25. There will be an
      effort to include gender and ethnicity with distribution seen in the Madison population.

      C. Recruitment: Recruitment will be conducted through placement of recruitment flyers
      throughout the UW-Madison, MATC, and Edgewood campuses as well as the greater Madison area.
      Recruitment will also use recruitment flyer in electronic form to advertise and through
      Craig's List and newspaper ads. These will all use identical format as is used in the flyer.
      For each of these mediums, an electronic version of the recruitment flyer will be posted.
      Recruitment will also included one-minute presentations to classes by personnel or the
      faculty/staff teaching the class. This will entail showing a power point slide with the
      electronic recruitment flyer, and may or may not include reading it out loud to students.
      This will only occur if the professor of a particular class agrees to this one minute
      presentation. Advertisements will state that the intervention is designed to help
      participants quit smoking. An effort will also be made to include minority students in a
      percentage that reflects university minority enrollment. Respondents will be screened by
      phone for the criteria listed below. Those who meet criteria will be scheduled for an
      orientation session, which will describe the intervention. Interested individuals will be
      offered the consent form, after which, randomization to study group or control group will be
      performed via random number generation. Recruitment will continue until 30 controls and 30
      group participants (3 cohorts of 10) have been enrolled or until statistical significance
      between groups is reached. Subjects will be paid $20 at the quit day, the 2 week post-quit
      visit, and $40 at the 8-week and 6-month post-quit visits (total of $120). In addition to a
      total of $120 per participant payment, participants who come to all 4 data collection days
      will have their name put in a "lottery" drawing for $1000.

      Inclusions: 1) Age 18 to 29 years; 2) Tobacco use of at least 10 cigarettes per day for at
      least 6 months; and, 3) Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for a
      male, 4 or more for a female). Rationale for Inclusions: Tobacco use levels are set to allow
      for a broad range of daily tobacco use, while eliminating occasional smokers. Alcohol use set
      at this level to include the majority of student smokers (known to drink at this level) and
      provide outcomes information on co-treatment of alcohol and tobacco.

      Exclusions: 1) A baseline (orientation meeting) CO level < 10, 2) Self report of pre-existing
      diagnosis of bipolar disorder, schizophrenia or other delusional disorder; 3) Self report of
      pre-existing diagnosis of personality disorder (e.g., borderline, antisocial, schizoaffective
      personality disorders). 4) Self report of alcohol use of 4 drinks or more a night on 6 or
      more nights per week.

      Rationale for Exclusions: Bipolar disorder, Schizophrenia, delusional disorders, and
      personality disorders are used as exclusions because of the high potential for individuals
      with these disorders to disrupt other participants in therapeutic group session. A CO level
      of 10 is required to establish a minimal level of tobacco dependence. High level alcohol use
      is an exclusion criterion because these individuals may withdraw from alcohol during alcohol
      reduction.

      Hypothesis: The primary hypothesis is that the mindfulness intervention will yield
      statistically significantly higher smoking abstinence than controls as measured by carbon
      monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post
      smoking cessation attempt).

      D. Safety Monitoring Plan This study proposes to obtain information from participants about
      their age, race, gender, as well as psychiatric and drug use information. All data from human
      subjects in this research protocol will be obtained by interview or questionnaire and will be
      obtained specifically for research purposes. Subject names will not be kept on data records,
      but instead, a standardized code will be used for identification. Access to these code
      numbers will be limited to staff members of the research team. All collected forms will be
      stored in locked file cabinets. Patient identifiers will be kept in separate files from the
      data forms. All patient identifiers will be destroyed at the end of the trial. No existing
      records or data will be utilized. Alcohol Withdrawal: Symptoms of alcohol withdrawal in
      clinically dependent drinkers include sweating, nervousness, nausea and vomiting, headaches,
      myalgias, tremors, delusions, hallucinations, seizures and death. Heavy drinkers (4 or more
      drinks/day) will be excluded from the study to ensure that subjects with a potential for
      clinical withdrawal are not in the study. Nonetheless, participants will be instructed that
      if symptoms of withdrawal occur, they are to report immediately to the emergency room for
      treatment and notify Dr. Davis (PI) of their condition. Dr. Davis is board certified in
      Internal Medicine and routinely manages patients in alcohol withdrawal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking Abstinence
time frame: 2 weeks post quit day
description: Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day
measure: Alcohol Use in Study Subjects vs Controls
time frame: 2 weeks post quit day
description: Timeline follow back participant self-report of daily alcohol use.
arm group label: Mindfulness Training for Smokers
arm group type: Active Comparator
description: Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.
arm group label: Interactive Learning for Smokers
arm group type: Active Comparator
description: Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.
intervention type: Behavioral
intervention name: Mindfulness Training for Smokers
description: The provides the Mindfulness Training for Smokers intervention (7 weeks long).
arm group label: Mindfulness Training for Smokers
other name: Study Group
intervention type: Behavioral
intervention name: Interactive Learning for Smokers
description: This provides the Interactive Learning for Smokers intervention (7 weeks long).
arm group label: Interactive Learning for Smokers
other name: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
last name: James M Davis, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Participants were not blinded to their respective treatment conditions.
Attrition reduced power and generalizability.
point of contact: 