Nicotine Dependence
Conditions
Keywords
Smoking, Smoking cessation, Nicotine, Tobacco, Mindfulness, Meditation, MBSR, Mindfulness Training, Behavioral Intervention, Nicotine Patch, Quit Line, Phone counseling
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.
Interventions
BEHAVIORALQuit Line plus MTS
This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
BEHAVIORALQuit Line Only
The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 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
| Measure | Time frame |
|---|---|
| Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls | 6 months post quit day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. | 91 |
| 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.
Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention. | 105 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 32 | 46 |
Baseline characteristics
| Characteristic | Quit Line Only | Quit Line Plus MTS | Total |
|---|---|---|---|
| Age, Continuous | 40.95 years STANDARD_DEVIATION 12.05 | 42.25 years STANDARD_DEVIATION 14.53 | 41.65 years STANDARD_DEVIATION 13.92 |
| Region of Enrollment United States | 91 participants | 105 participants | 196 participants |
| Sex: Female, Male Female | 45 Participants | 53 Participants | 98 Participants |
| Sex: Female, Male Male | 46 Participants | 52 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 91 | 0 / 105 |
| serious Total, serious adverse events | 0 / 91 | 0 / 105 |
Outcome results
Primary
Smoking Abstinence
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
Population: intent to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quit Line Only | Smoking Abstinence | 13 participants |
| Quit Line Plus MTS | Smoking Abstinence | 24 participants |
Secondary
Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls
Time frame: 6 months post quit day