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
2 other identifiers
interventional
196
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
February 16, 2015
CompletedOctober 20, 2015
January 1, 2015
3.8 years
March 24, 2010
May 17, 2014
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls
6 months post quit day
Study Arms (2)
Quit Line Only
ACTIVE COMPARATORControl Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Quit Line plus MTS
ACTIVE COMPARATORParticipants 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.
Interventions
This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Eligibility Criteria
You may qualify if:
- Age: 18 years or over;
- Participants must express "high" motivation to quit smoking
- Participants must express willingness to attend "all" meetings for 2 months.
- Smoke 5 or more cigarettes per day
You may not qualify if:
- Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
- Self report of using chewing tobacco, snuff or cigars in the last week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711, United States
Related Publications (2)
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.
PMID: 24611852RESULTJackson 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.
PMID: 35420700DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A principal limitation of this study is that it is designed to compare MTS to a less intensive usual care therapy and as such lacks a time/intensity matched control.
Results Point of Contact
- Title
- James M. Davis MD, Assistant Professor, Duke University
- Organization
- University of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
James M Davis, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 26, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 20, 2015
Results First Posted
February 16, 2015
Record last verified: 2015-01