Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Smoking Abstinence
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18 to 29 years
- •Tobacco use of at least 10 cigarettes per day for at least 6 months
- •Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for males, 4 or more for females)
Exclusion Criteria
- •Baseline (orientation meeting) CO level < 10
- •Self report of pre-existing bipolar disorder, schizophrenia, other delusional disorder
- •Self report of pre-existing diagnosis of personality disorder (e.g. borderline, antisocial, schizoaffective personality disorders)
- •Self report of alcohol use of 4 drinks or more on 6 or more nights per week.
Arms & Interventions
Mindfulness Training for Smokers
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.
Intervention: Mindfulness Training for Smokers (Behavioral)
Interactive Learning for Smokers
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: Interactive Learning for Smokers (Behavioral)
Outcomes
Primary Outcomes
Smoking Abstinence
Time Frame: 2 weeks post quit day
Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day
Secondary Outcomes
- Alcohol Use in Study Subjects vs Controls(2 weeks post quit day)