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Completed

NCT Number: NCT01093599

Trial on the Effectiveness of Mindfulness Training for Smokers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madison, Wisconsin, 53711, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Quit Line plus MTS

Behavioral

This provides the quit line intervention plus the Mindfulness for Smokers Intervention.

Other names: Study Group, Quit Line Plus Mindfulness Training for Smokers

Quit Line Only

Behavioral

The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.

Other names: Control Group

Primary outcomes

  1. Smoking Abstinence

    Time frame: 6 months post quit day

    Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.

Secondary outcomes

  1. Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls

    Time frame: 6 months post quit day

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: MTS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2010
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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