Trial on the Effectiveness of Mindfulness Training for Smokers (MTS)

Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking

The Mindfulness Training for Smokers study follows a randomized controlled design with 240 total participants. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control group will receive the Quit Line intervention alone where as the study group will receive the Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by four weeks of participation in a weekly meditation group. The principal hypothesis for the study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher rates of smoking cessation at 6 months than the Quit Line alone.

Study Overview

• Status: Completed
• Conditions: Nicotine Dependence
• Intervention / Treatment: Behavioral: Quit Line Only; Behavioral: Quit Line plus MTS

Detailed Description

The MTS study is funded for through a five year K23 NIH training grant. The study follows a randomized controlled design with N = 240. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line, will receive four weeks of nicotine patches, and receive phone based counseling through the Quit Line. The control group n = 120 will receive the Quit Line intervention alone where as the study group n = 120 will receive the Quit Line intervention plus the Mindfulness Training for Smokers (MTS) Intervention.

Mindfulness Training for Smokers provides 4 weeks of mindfulness meditation instruction followed by entry into a MTS meditation group. The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be four years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through the television and radio advertisements (appendix). In addition, the Wisconsin Quit Line web site will provide a link to the MTS study. With this link, quit line coaches will have a brief description of the study (see appendix) and will provide contact information for the study. Finally, the MTS web site (url: www.sittoquit.org) will provide basic introductory information available to the general public.

The principal hypothesis for the study is that MTS plus Quit Line will lead to significantly higher rates of smoking cessation at 6 months than use of the Quit Line alone. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53711
      • University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 18 years or over;
2. Participants must express "high" motivation to quit smoking
3. Participants must express willingness to attend "all" meetings for 2 months.
4. Smoke 5 or more cigarettes per day

Exclusion Criteria:

1. Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
2. Self report of using chewing tobacco, snuff or cigars in the last week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quit Line Only; Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.	Behavioral: Quit Line Only; The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.; Other Names: Control Group
Active Comparator: Quit Line plus MTS; Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.	Behavioral: Quit Line plus MTS; This provides the quit line intervention plus the Mindfulness for Smokers Intervention.; Other Names: Study Group; Quit Line Plus Mindfulness Training for Smokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Abstinence	Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.	6 months post quit day

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls	6 months post quit day

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: James M Davis, MD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
• Davis JM, Goldberg SB, Anderson MC, Manley AR, Smith SS, Baker TB. Randomized trial on mindfulness training for smokers targeted to a disadvantaged population. Subst Use Misuse. 2014 Apr;49(5):571-85. doi: 10.3109/10826084.2013.770025.

Helpful Links

• Randomized trial on mindfulness training for smokers targeted to a disadvantaged population.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 25, 2010
• First Posted (Estimate): March 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: September 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Smoking; Mindfulness; Smoking cessation; Tobacco; Meditation; Behavioral Intervention; Nicotine; MBSR; Mindfulness Training; Nicotine Patch; Quit Line; Phone counseling
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: H-2009-0039; 1K23DA022471-01A1 (U.S. NIH Grant/Contract)