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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quit Line plus MTS
Quit Line Only
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Smoking, Smoking cessation, Nicotine, Tobacco, Mindfulness, Meditation, MBSR, Mindfulness Training, Behavioral Intervention, Nicotine Patch, Quit Line, Phone counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quit Line Only

Quit Line plus MTS

Arm Description

Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.

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.

Outcomes

Primary Outcome Measures

Smoking Abstinence
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

Full Information

First Posted
March 24, 2010
Last Updated
September 30, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01093599
Brief Title
Trial on the Effectiveness of Mindfulness Training for Smokers
Acronym
MTS
Official Title
Phase 2 Randomized Trial on the Effectiveness of Mindfulness Training for Smokers, a Novel Intervention Designed to Help Smokers Quit Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Smoking, Smoking cessation, Nicotine, Tobacco, Mindfulness, Meditation, MBSR, Mindfulness Training, Behavioral Intervention, Nicotine Patch, Quit Line, Phone counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quit Line Only
Arm Type
Active Comparator
Arm Description
Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Arm Title
Quit Line plus MTS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quit Line plus MTS
Other Intervention Name(s)
Study Group, Quit Line Plus Mindfulness Training for Smokers
Intervention Description
This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Quit Line Only
Other Intervention Name(s)
Control Group
Intervention Description
The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Primary Outcome Measure Information:
Title
Smoking Abstinence
Description
Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.
Time Frame
6 months post quit day
Secondary Outcome Measure Information:
Title
Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls
Time Frame
6 months post quit day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Davis, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24611852
Citation
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.
Results Reference
result
PubMed Identifier
35420700
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24611852
Description
Randomized trial on mindfulness training for smokers targeted to a disadvantaged population.

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Trial on the Effectiveness of Mindfulness Training for Smokers

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