Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Condition: Nicotine Dependence; Alcohol Use
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness Training for Smokers; Interactive Learning for Smokers
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The provides the Mindfulness Training for Smokers intervention (7 weeks long).; This provides the Interactive Learning for Smokers intervention (7 weeks long).
Other intervention name(s): Study Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Smoking cessation; Nicotine; Tobacco; Mindfulness; Meditation; MBSR; Mindfulness Training; Behavioral Intervention; Alcohol; Young Adults