Trial on the Effectiveness of Mindfulness Training for Smokers

Study Overview
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Brief Summary
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The Mindfulness Training for Smokers study follows a randomized controlled design with 240 total participants. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control group will receive the Quit Line intervention alone where as the study group will receive the Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by four weeks of participation in a weekly meditation group. The principal hypothesis for the study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher rates of smoking cessation at 6 months than the Quit Line alone.

Detailed Description
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The MTS study is funded for through a five year K23 NIH training grant. The study follows a randomized controlled design with N = 240. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line, will receive four weeks of nicotine patches, and receive phone based counseling through the Quit Line. The control group n = 120 will receive the Quit Line intervention alone where as the study group n = 120 will receive the Quit Line intervention plus the Mindfulness Training for Smokers (MTS) Intervention. Mindfulness Training for Smokers provides 4 weeks of mindfulness meditation instruction followed by entry into a MTS meditation group. The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be four years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through the television and radio advertisements (appendix). In addition, the Wisconsin Quit Line web site will provide a link to the MTS study. With this link, quit line coaches will have a brief description of the study (see appendix) and will provide contact information for the study. Finally, the MTS web site (url: www.sittoquit.org) will provide basic introductory information available to the general public. The principal hypothesis for the study is that MTS plus Quit Line will lead to significantly higher rates of smoking cessation at 6 months than use of the Quit Line alone. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life.

Official Title
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Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: Quit Line plus MTS
* Behavioral: Quit Line Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or over; Participants must express high motivation to quit smoking Participants must express willingness to attend all meetings for 2 months. Smoke 5 or more cigarettes per day Exclusion Criteria: Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week. Self report of using chewing tobacco, snuff or cigars in the last week.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quit Line Only<br>Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. | Behavioral: Quit Line Only<br>* The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.<br>* Other names: Control Group;|
| Active Comparator: Quit Line plus MTS<br>Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention. | Behavioral: Quit Line plus MTS<br>* This provides the quit line intervention plus the Mindfulness for Smokers Intervention.<br>* Other names: Quit Line Plus Mindfulness Training for Smokers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day. | 6 months post quit day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls |  | 6 months post quit day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking cessation, Nicotine, Tobacco, Mindfulness, Meditation, MBSR, Mindfulness Training, Behavioral Intervention, Nicotine Patch, Quit Line, Phone counseling