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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA018875 | U.S. NIH Grant/Contract | View source | |
| NCI-2012-02081 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.
This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures.
Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT. UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline). ST is a standard smoking cessation group program using a problem-solving/coping skills approach. MBAT is a group smoking cessation program derived from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. MBAT will not alter the basic mindfulness approach used in MBCT and MBSR, but will replace depression-related material with smoking cessation strategies from the Guideline. All participants will receive nicotine patches and self-help materials. MBAT mechanisms and effects will be assessed using "implicit" cognitive psychological measures and computer-administered questionnaires. Participants will be tracked from baseline through 4 (UC) or 8 (ST and MBAT) treatment visits and follow-up visits 1 and 23 weeks post-treatment.
The overarching goals are to evaluate MBAT's efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.
Primary specific aims are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Treatment Group (MBAT) | Experimental | MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence. |
|
| Standard Care Group | Active Comparator | Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
|
| Usual Care Group | Active Comparator | Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBAT Group Therapy | Behavioral | In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach. | 4 weeks post quit day (one week following the end of treatment) |
| Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | 26 weeks post quit day |
| Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | 4 weeks post quit day (one week following the end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Wetter, Ph.D. | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 28191263 | Derived | Vidrine JI, Businelle MS, Reitzel LR, Cao Y, Cinciripini PM, Marcus MT, Li Y, Wetter DW. Coping Mediates the Association of Mindfulness with Psychological Stress, Affect, and Depression Among Smokers Preparing to Quit. Mindfulness (N Y). 2015 Jun;6(3):433-443. doi: 10.1007/s12671-014-0276-4. Epub 2014 Jan 18. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Out of the 650 participants, 412 were on the formal clinical trial and 238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.
Participants were recruited from the Houston metropolitan area via local print media. All data collected between January 2007 to February 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Group | Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
| FG001 | Cognitive Behavioral Treatment (CBT) | Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
| FG002 | Mindfulness-Based Treatment Group (MBAT) | MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Group (UC) | 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline |
| BG001 | Cognitive Behavioral Treatment (CBT) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach. | Completers-only | Posted | Count of Participants | Participants | 4 weeks post quit day (one week following the end of treatment) |
|
Adverse event data collected up to 32 weeks of treatment.
MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events.No SAE's nor Adverse Events occurred in this protocol to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation report submission. 238 participants were registered under the pilot phase which were not included in the formal clinical trial and no data collected.participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Group | Usual Care (UC) 6 weeks of nicotine patch therapy, Self-help guide & In-person individual counseling (4 sessions over 8 weeks) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical | UT MD Anderson Cancer Center | 713-563-0020 | sgiordan@mdanderson.org |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003376 | Counseling |
| D009538 | Nicotine |
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
| Nicotine | Drug | 6 weeks of nicotine patch therapy |
|
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| Group Therapy | Behavioral | In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
|
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| Individual Therapy | Behavioral | In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline |
|
|
6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline |
| BG002 | Mindfulness-Based Treatment Group (MBAT) | 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Kentucky Inventory of Mindfulness Skills (KIMS) | The Kentucky Inventory of Mindfulness Skills (KIMS) is a self-report inventory for the assessment of mindfulness skills (including subscales for observing (15-59), describing (10-40), acting with awareness (15-48), and accept(13-45) . Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. The minimum score 10 and maximum score 59. Higher-scores reflect more mindfulness. | Mean | Standard Deviation | KIMS Score |
|
| Mindful Attention Awareness Scale (MAAS) | The Mindful Attention Awareness Scale (MAAS) is a 15 item self-report questionnaire measuring mindfulness. To score the scale, simply compute a mean (average) of the 15 items. Items are rated on using the 1-6 scale ranging from 1 (almost always) to 6 (almost never). Indicates currently how frequently or infrequently each experience. | Mean | Standard Deviation | MAAS Score |
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| Nicotine Dependence - Cigarettes per day | Nicotine Dependence was assessed at baseline using the Heaviness of Smoking Index (HIS). The HSI comprises the two items from the Fagerstrom Test for Nicotine Dependence (FTND) that most strongly predict smoking relapse, cigarettes per day (CPD) and minutes to the first cigarette after waking. | Mean | Standard Deviation | Cigarettes per day |
|
| Nicotine Dependence - Participants reported smoking their first cigarette with 5 minutes of walking | Nicotine Dependence was assessed at baseline using the Heaviness of Smoking Index (HIS). The HSI comprises the two items from the Fagerstrom Test for Nicotine Dependence (FTND) that most strongly predict smoking relapse, cigarettes per day (CPD) and minutes to the first cigarette after waking. | Count of Participants | Participants |
|
| Demographics (Education) | Years of Education | Count of Participants | Participants |
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| Demographics (Household Income) | Income: self-reported household income | Count of Participants | Participants |
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| Demographics (Spouse/Partner) | Relationship status: self-report of participants with no partner | Count of Participants | Participants |
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| Demographics (History of Depression) | The Center of Epidemiologic Studies Depression Scale (CES-D) assesses depressive symptoms in community non-clinical populations | Count of Participants | Participants |
|
| OG002 | Mindfulness-Based Treatment Group (MBAT) | 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence |
|
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| Primary | Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | Completers Only | Posted | Count of Participants | Participants | 26 weeks post quit day |
|
|
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| Primary | Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | Intent to treat | Posted | Count of Participants | Participants | 4 weeks post quit day (one week following the end of treatment) |
|
|
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| Primary | Smoking Abstinence | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach | Intent to treat | Posted | Count of Participants | Participants | 26 weeks post quit day |
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|
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Standard Care Group | Standard Care Group (ST) 6 weeks of nicotine patch therapy, Self-help guide & In-person group therapy/counseling (8 sessions over 8 weeks) | 0 | 155 | 0 | 155 |
| EG002 | Mindfulness-Based Treatment Group (MBAT) | MBAT 6 weeks of nicotine patch therapy; Self-help guide; & In-person group therapy/counseling (8 sessions over 8 weeks) using a MBAT for nicotine dependence. | 0 | 154 | 0 | 154 |
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| D005159 | Health Care Facilities Workforce and Services |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |