Study Two on the Effectiveness of Mindfulness Training for Smokers

NCT01299909 | Completed Results DMC

• 2 other identifiers: 2011-00871K23DA022471-01A1
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.

Conditions

Nicotine Dependence

Keywords

Mindfulness Training for Smokers; Smoking; Smoking cessation; Addiction; behavioral intervention; Nicotine; Tobacco; Mindfulness; Meditation; MBSR; Mindfulness Based Stress Reduction; Mindfulness Based Cognitive Therapy; MBCT; Mindfulness Based Relapse Prevention; MBRP; Mindfulness Training; Nicotine Patch; Quit Line; Phone counseling; Freedom from Smoking

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence

  Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.

  24 weeks post quit day

Secondary Outcomes (3)

• Five Facet Mindfulness Questionnaire (FFMQ)

  24 weeks post-quit

• Acceptance and Action Questionnaire (AAQ)

  24 weeks post-quit

• Perceived Stress Scale (PSS)

  24 weeks post-quit

Study Arms (3)

Mindfulness Training for Smokers

ACTIVE COMPARATOR

MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.

Behavioral: Mindfulness Training for Smokers

Integrated Training for Smokers

ACTIVE COMPARATOR

ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.

Behavioral: Integrated Training for Smokers

Quitline

OTHER

Quitline participants will consist of participants who elect not to participate in the high-intensity treatments (Mindfulness Training for Smokers; Integrated Training for Smokers. This Quitline group is a Non-Randomized, Treatment as Usual group.

Behavioral: Quitline

Interventions

Integrated Training for Smokers BEHAVIORAL

8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program

Also known as: Control Group, ITS

Integrated Training for Smokers

Mindfulness Training for Smokers BEHAVIORAL

8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.

Also known as: Study Group, MTS

Mindfulness Training for Smokers

Quitline BEHAVIORAL

Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.

Also known as: Non-Randomized, Treatment as Usual

Quitline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• High score on Patient Health Questionnaire Depression Screening Tool for severe depression and suicidal intention.

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 (2)

• Davis JM, Manley AR, Goldberg SB, Smith SS, Jorenby DE. Randomized trial comparing mindfulness training for smokers to a matched control. J Subst Abuse Treat. 2014 Sep;47(3):213-21. doi: 10.1016/j.jsat.2014.04.005. Epub 2014 May 2.

  PMID: 24957302 RESULT

• 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.

  PMID: 35420700 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation; Behavior, Addictive

Interventions

Control Groups; Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Stevens S. Smith, Ph.D.
• Organization: University of Wisconsin

sss@ctri.wisc.edu

608-262-7563

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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 27, 2019
• Results First Posted: February 1, 2017

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after June 2014 from Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
• Access Criteria: Other researchers will need to contact the Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).

Locations

US (1)