Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA022471-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quit Line Only | Active Comparator | Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. |
|
| Quit Line plus MTS | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quit Line plus MTS | Behavioral | This provides the quit line intervention plus the Mindfulness for Smokers Intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day. | 6 months post quit day |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls | 6 months post quit day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James M Davis, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | Madison | Wisconsin | 53711 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24611852 | Result | 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. | |
| 35420700 | Derived | 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. |
| Label | URL |
|---|---|
| Randomized trial on mindfulness training for smokers targeted to a disadvantaged population. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
total enrolled
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence | Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day. | intent to treat analysis | Posted | Number | participants | 6 months post quit day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
A principal limitation of this study is that it is designed to compare MTS to a less intensive usual care therapy and as such lacks a time/intensity matched control.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James M. Davis MD, Assistant Professor, Duke University | University of Wisconsin | 608-217-9405 | jjamesdavis@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quit Line Only | Behavioral | The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches. |
|
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls | Not Posted | 6 months post quit day |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | 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. | 0 | 105 | 0 | 105 |
Not provided
Not provided
| D015438 |
| Health Behavior |
| D008722 | Methods |