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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Davis, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01093599
First received: March 24, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Behavioral: Quit Line plus MTS
Behavioral: Quit Line Only
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Smoking Abstinence [ Time Frame: 6 months post quit day ] [ Designated as safety issue: No ]
    Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.


Secondary Outcome Measures:
  • Changes in self reported measures of depression, anxiety and stress in study subjects vs controls [ Time Frame: 6 months post quit day ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093599

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: James M Davis, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: James Davis, James M. Davis, MD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01093599     History of Changes
Other Study ID Numbers: H-2009-0039, 1K23DA022471-01A1
Study First Received: March 24, 2010
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Smoking cessation
Nicotine
Tobacco
Mindfulness
Meditation
MBSR
Mindfulness Training
Behavioral Intervention
Nicotine Patch
Quit Line
Phone counseling

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014