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Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01679236
Recruitment Status : Completed
First Posted : September 5, 2012
Results First Posted : June 24, 2014
Last Update Posted : June 24, 2014
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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).

Condition or disease Intervention/treatment Phase
Nicotine Dependence Alcohol Use Behavioral: Mindfulness Training for Smokers Behavioral: Interactive Learning for Smokers Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Mindfulness Training for Smokers
The provides the Mindfulness Training for Smokers intervention (7 weeks long).
Other Name: Study Group

Active Comparator: 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.
Behavioral: Interactive Learning for Smokers
This provides the Interactive Learning for Smokers intervention (7 weeks long).
Other Name: Control Group

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Alcohol Use in Study Subjects vs Controls [ Time Frame: 2 weeks post quit day ]
    Timeline follow back participant self-report of daily alcohol use.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01679236

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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
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Principal Investigator: James M Davis, MD University of Wisconsin, Madison

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01679236    
Other Study ID Numbers: H-2006-0279
P50DA019706-09 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2012    Key Record Dates
Results First Posted: June 24, 2014
Last Update Posted: June 24, 2014
Last Verified: May 2014
Keywords provided by University of Wisconsin, Madison:
Smoking cessation
Mindfulness Training
Behavioral Intervention
Young Adults
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs