Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
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ClinicalTrials.gov Identifier: NCT01679236 |
Recruitment Status :
Completed
First Posted : September 5, 2012
Results First Posted : June 24, 2014
Last Update Posted : June 24, 2014
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Condition or disease | Intervention/treatment | Phase |
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Nicotine Dependence Alcohol Use | Behavioral: Mindfulness Training for Smokers Behavioral: Interactive Learning for Smokers | Early Phase 1 |

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 |

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.
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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.
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Behavioral: Interactive Learning for Smokers
This provides the Interactive Learning for Smokers intervention (7 weeks long).
Other Name: Control Group |
- 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
- Alcohol Use in Study Subjects vs Controls [ Time Frame: 2 weeks post quit day ]Timeline follow back participant self-report of daily alcohol use.

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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:
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01679236
United States, Wisconsin | |
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | |
Madison, Wisconsin, United States, 53711 |
Principal Investigator: | James M Davis, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov 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 |
Smoking Smoking cessation Nicotine Tobacco Mindfulness Meditation |
MBSR Mindfulness Training Behavioral Intervention Alcohol Young Adults |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |