Smoking, Tobacco Use Cessation
Conditions
Keywords
Tobacco Cessation, Smoking Cessation
Brief summary
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.
Detailed description
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: 1. Examine the effects of MBAT on abstinence rates 2. Examine the effects of MBAT on mindfulness/metacognitive awareness, attentional control, smoking automaticity, smoking associations in memory, negative affect, depression, stress, affect regulation expectancies, self-efficacy, withdrawal, and coping across the pre- and post-cessation period, and whether these variables mediate MBAT effects on abstinence.
Interventions
BEHAVIORALMBAT Group Therapy
In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
DRUGNicotine
6 weeks of nicotine patch therapy
BEHAVIORALGroup Therapy
In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
BEHAVIORALIndividual Therapy
In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Sponsors
National Institute on Drug Abuse (NIDA)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 or above 2. Current smoker with a history of at least five cigarettes/day for the past year 3. Motivated to quit within the next 30 days (preparation stage) 4. Participants must provide a viable home address and a functioning home telephone number 5. Can read and write in English 6. Register 8 or more on a carbon monoxide breath test 7. Provide viable collateral contact information
Exclusion criteria
1. Contraindication for nicotine patch use 2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco) 3. Use of bupropion or nicotine patch replacement products other than the study patches 4. Pregnancy or lactation 5. Another household member enrolled in the study 6. Active substance dependence (exclusive of nicotine dependence) 7. Current psychiatric disorder; current use of psychotropic medication 8. Participation in a smoking cessation program or study during the past 90 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence | 4 weeks post quit day (one week following the end of treatment) | Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach. |
| Smoking Abstinence | 26 weeks post quit day | Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Houston metropolitan area via local print media. All data collected between January 2007 to February 2010.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| Cognitive Behavioral Treatment (CBT) 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 | 155 |
| 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 | 154 |
| Total | 412 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 54 | 51 |
Baseline characteristics
| Characteristic | Usual Care Group (UC) | Cognitive Behavioral Treatment (CBT) | Mindfulness-Based Treatment Group (MBAT) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants | 155 Participants | 154 Participants | 412 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 12.5 | 48.8 years STANDARD_DEVIATION 11.9 | 48.4 years STANDARD_DEVIATION 11.7 | 48.7 years STANDARD_DEVIATION 11.9 |
| Demographics (Education) > 4-year College Degree | 6 Participants | 11 Participants | 6 Participants | 23 Participants |
| Demographics (Education) 4-year College Degree | 10 Participants | 17 Participants | 28 Participants | 55 Participants |
| Demographics (Education) < High School | 10 Participants | 13 Participants | 14 Participants | 37 Participants |
| Demographics (Education) High School/GED | 25 Participants | 37 Participants | 39 Participants | 101 Participants |
| Demographics (Education) Some College | 52 Participants | 76 Participants | 67 Participants | 195 Participants |
| Demographics (History of Depression) | 22 Participants | 27 Participants | 22 Participants | 71 Participants |
| Demographics (Household Income) < $30,000/year | 61 Participants | 89 Participants | 87 Participants | 237 Participants |
| Demographics (Household Income) > $30,000/year | 42 Participants | 66 Participants | 67 Participants | 175 Participants |
| Demographics (Spouse/Partner) | 76 Participants | 103 Participants | 109 Participants | 288 Participants |
| Kentucky Inventory of Mindfulness Skills (KIMS) | 31.9 KIMS Score STANDARD_DEVIATION 4 | 31.9 KIMS Score STANDARD_DEVIATION 3.6 | 32.0 KIMS Score STANDARD_DEVIATION 3.8 | 32.0 KIMS Score STANDARD_DEVIATION 3.8 |
| Mindful Attention Awareness Scale (MAAS) | 4.2 MAAS Score STANDARD_DEVIATION 0.9 | 4.3 MAAS Score STANDARD_DEVIATION 0.9 | 4.3 MAAS Score STANDARD_DEVIATION 1 | 4.3 MAAS Score STANDARD_DEVIATION 0.9 |
| Nicotine Dependence - Cigarettes per day | 19.3 Cigarettes per day STANDARD_DEVIATION 8.6 | 19.9 Cigarettes per day STANDARD_DEVIATION 9.3 | 20.3 Cigarettes per day STANDARD_DEVIATION 11.7 | 19.9 Cigarettes per day STANDARD_DEVIATION 10.1 |
| Nicotine Dependence - Participants reported smoking their first cigarette with 5 minutes of walking | 39 Participants | 61 Participants | 59 Participants | 159 Participants |
| Region of Enrollment United States | 103 participants | 155 participants | 154 participants | 412 participants |
| Sex: Female, Male Female | 58 Participants | 84 Participants | 84 Participants | 226 Participants |
| Sex: Female, Male Male | 45 Participants | 71 Participants | 70 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 155 | 0 / 154 |
| serious Total, serious adverse events | 0 / 103 | 0 / 155 | 0 / 154 |
Outcome results
Primary
Number of Participants With Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
Time frame: 4 weeks post quit day (one week following the end of treatment)
Population: Completers-only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group (UC) | Number of Participants With Smoking Abstinence | 21 Participants |
| Cognitive Behavioral Treatment (CBT) | Number of Participants With Smoking Abstinence | 39 Participants |
| Mindfulness-Based Treatment Group (MBAT) | Number of Participants With Smoking Abstinence | 43 Participants |
Primary
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Time frame: 26 weeks post quit day
Population: Completers Only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group (UC) | Smoking Abstinence | 13 Participants |
| Cognitive Behavioral Treatment (CBT) | Smoking Abstinence | 24 Participants |
| Mindfulness-Based Treatment Group (MBAT) | Smoking Abstinence | 20 Participants |
Primary
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Time frame: 4 weeks post quit day (one week following the end of treatment)
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group (UC) | Smoking Abstinence | 25 Participants |
| Cognitive Behavioral Treatment (CBT) | Smoking Abstinence | 50 Participants |
| Mindfulness-Based Treatment Group (MBAT) | Smoking Abstinence | 52 Participants |
Primary
Smoking Abstinence
Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
Time frame: 26 weeks post quit day
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group (UC) | Smoking Abstinence | 12 Participants |
| Cognitive Behavioral Treatment (CBT) | Smoking Abstinence | 24 Participants |
| Mindfulness-Based Treatment Group (MBAT) | Smoking Abstinence | 53 Participants |