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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.
The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. Twelve subjects (50% female, ages 18-65) who meet Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for both marijuana and nicotine dependence and seek treatment to stop using both marijuana and tobacco will receive individual CBT aimed at treating both disorders, as well as Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch. Subjects will start with a 21-mg nicotine patch for 6 weeks, followed by a taper to a 14-mg nicotine patch for 2 weeks and, finally, a 7-mg nicotine patch for 2 weeks. Others will start with a 14-mg patch for 8 weeks followed by a 7-mg patch for 2 weeks. All participants will receive 10 weeks of 1-hour weekly CBT with an experienced clinician. Follow-up visits, scheduled at 4, 6, 8, and 10 weeks, will evaluate of the durability of treatment effects on drug use and psychosocial outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | individual CBT once weekly, 50 minutes, for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Use | cigarettes per day | Baseline and 10 weeks |
| Cannabis Use | cannabis inhalations per day | Baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks | The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin P Hill, MD, MHS | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15279529 | Background | Marijuana Treatment Project Research Group. Brief treatments for cannabis dependence: findings from a randomized multisite trial. J Consult Clin Psychol. 2004 Jun;72(3):455-66. doi: 10.1037/0022-006X.72.3.455. | |
| Background | Hill, K.P., and Chang, G. Cognitive Behavioral Therapy and Nicotine Replacement for Smoking Cessation in Psychiatric Outpatients with Major Depression. Addictive Disorders and Their Treatment, 6: 67-72, 2007. | ||
| 8034816 |
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Four participants were determined to be ineligible due to significant active Axis I psychopathology other than nicotine or cannabis dependence, one was ineligible due to an active medical issue that was referred for treatment, and one was ineligible due to a positive urine toxicology screen for an illicit substance other than cannabis.
Subjects were recruited via online and newspaper advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | CBT plus NRT |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Cigarette Use | cigarettes per day | Posted | Mean | Standard Deviation | cigarettes/day | Baseline and 10 weeks |
|
|
10 weeks
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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 | Treatment | CBT plus NRT |
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slightly more than one-third of participants did not complete treatment. The small sample size and relatively high proportion of treatment non-completers may limit our interpretation of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin P Hill, MD, MHS | McLean Hospital | 617-855-4501 | khill@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000095488 | Nicotine Replacement Therapy |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004358 | Drug Therapy |
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| Nicotine Replacement Therapy | Drug |
|
|
|
| Background |
| Hall SM, Munoz RF, Reus VI. Cognitive-behavioral intervention increases abstinence rates for depressive-history smokers. J Consult Clin Psychol. 1994 Feb;62(1):141-6. doi: 10.1037//0022-006x.62.1.141. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Cannabis Use | cannabis inhalations per day | Posted | Mean | Standard Deviation | cannabis inhalations/day | Baseline and 10 weeks |
|
|
|
| Secondary | Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks | The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction. | Posted | Mean | Standard Deviation | Scores on a scale | 10 weeks |
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| 0 |
| 7 |
| 0 |
| 7 |
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| D001519 | Behavior |
| D013812 |
| Therapeutics |