Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Smoking Abstinence
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Smoking Abstinence
时间窗: 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
次要结局
- Alcohol Use in Study Subjects vs Controls(2 weeks post quit day)