Pilot Study on Mindfulness for Tobacco and Alcohol in University Students

NCT01679236 | Completed Early Phase 1 Results DMC

• 2 other identifiers: H-2006-0279P50DA019706-09
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Nicotine Dependence; Alcohol Use

Keywords

Smoking; Smoking cessation; Nicotine; Tobacco; Mindfulness; Meditation; MBSR; Mindfulness Training; Behavioral Intervention; Alcohol; Young Adults

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Alcohol Use in Study Subjects vs Controls

  2 weeks post quit day

Study Arms (2)

Mindfulness Training for Smokers

ACTIVE COMPARATOR

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

Interactive Learning for Smokers

ACTIVE COMPARATOR

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

Interventions

Mindfulness Training for Smokers BEHAVIORAL

The provides the Mindfulness Training for Smokers intervention (7 weeks long).

Also known as: Study Group

Mindfulness Training for Smokers

Interactive Learning for Smokers BEHAVIORAL

This provides the Interactive Learning for Smokers intervention (7 weeks long).

Also known as: Control Group

Interactive Learning for Smokers

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

• Davis JM, Mills DM, Stankevitz KA, Manley AR, Majeskie MR, Smith SS. Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers. BMC Complement Altern Med. 2013 Sep 3;13:215. doi: 10.1186/1472-6882-13-215.

  PMID: 24006963 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Alcohol Drinking; Smoking; Smoking Cessation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

1. Participants were not blinded to their respective treatment conditions. 2. Attrition reduced power and generalizability.

Results Point of Contact

• Title: James M. Davis MD, Assistant Professor, Duke University
• Organization: University of Wisconsin

jjamesdavis@hotmail.com

608-217-9405

Study Officials

• James M Davis, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: September 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: June 24, 2014
• Results First Posted: June 24, 2014

Record last verified: 2014-05

Locations

US (1)