Nicotine Dependence Clinical Trial
Official title:
Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Verified date | May 2014 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 55 |
Est. completion date | September 2009 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 29 Years |
Eligibility |
Inclusion Criteria: 1. Age: 18 to 29 years 2. Tobacco use of at least 10 cigarettes per day for at least 6 months 3. Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for males, 4 or more for females) Exclusion Criteria: 1. Baseline (orientation meeting) CO level < 10 2. Self report of pre-existing bipolar disorder, schizophrenia, 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 on 6 or more nights per week. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Abstinence | Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day | 2 weeks post quit day | No |
Secondary | Alcohol Use in Study Subjects vs Controls | Timeline follow back participant self-report of daily alcohol use. | 2 weeks post quit day | No |
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