Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01679236
First received: August 31, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Nicotine Dependence
Alcohol Use
Behavioral: Mindfulness Training for Smokers
Behavioral: Interactive Learning for Smokers
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 2 weeks post quit day ] [ Designated as safety issue: No ]
    Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day


Secondary Outcome Measures:
  • Alcohol Use in Study Subjects vs Controls [ Time Frame: 2 weeks post quit day ] [ Designated as safety issue: No ]
    Timeline follow back participant self-report of daily alcohol use.


Enrollment: 55
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679236

Locations
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
Investigators
Principal Investigator: James M Davis, MD University of Wisconsin, Madison
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01679236     History of Changes
Other Study ID Numbers: H-2006-0279, P50DA019706-09
Study First Received: August 31, 2012
Results First Received: May 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Smoking cessation
Nicotine
Tobacco
Mindfulness
Meditation
MBSR
Mindfulness Training
Behavioral Intervention
Alcohol
Young Adults

Additional relevant MeSH terms:
Alcohol Drinking
Tobacco Use Disorder
Drinking Behavior
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014