Cannabis Dependence, Nicotine Dependence
Conditions
Keywords
cognitive behavioral therapy, nicotine dependence, cannabis dependence, smoking cessation, nicotine replacement therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
individual CBT once weekly, 50 minutes, for 10 weeks
DRUGNicotine Replacement Therapy
1. 21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks 2. 14 m g patch for 8 weeks, then 7 mg patch for 2 weeks
Sponsors
Harvard Medical School (HMS and HSDM)
Mclean Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range 18-65 years * current DSM-IV cannabis dependence * current DSM-IV nicotine dependence * express a desire to quit cannabis and nicotine use within the next 30 days * daily use of ≥ 10 tobacco cigarettes * for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and additional pregnancy tests at weeks 4 and 8 * Expired breath carbon monoxide (CO) determination is greater than or equal to 7 ppm over ambient values
Exclusion criteria
* Current diagnosis of other drug or alcohol dependence (other than cannabis or nicotine) * recent (within 3 months) significant cardiac disease * current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts * current use of bupropion * current NRT or other smoking cessation treatment * current CBT or other behavioral treatments for cessation of marijuana or tobacco smoking * current smokeless tobacco use * inability to read or write in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Use | Baseline and 10 weeks | cigarettes per day |
| Cannabis Use | Baseline and 10 weeks | cannabis inhalations per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited via online and newspaper advertisements.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment CBT plus NRT | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 28.2 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Cannabis Use
cannabis inhalations per day
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline - Cigarettes Per Day | Cannabis Use | 10.0 cannabis inhalations/day | Standard Deviation 5.3 |
| PostTreatment - Cigarettes Per Day | Cannabis Use | 8.0 cannabis inhalations/day | Standard Deviation 5.3 |
Primary
Cigarette Use
cigarettes per day
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline - Cigarettes Per Day | Cigarette Use | 12.6 cigarettes/day | Standard Deviation 4.9 |
| PostTreatment - Cigarettes Per Day | Cigarette Use | 2.1 cigarettes/day | Standard Deviation 4.2 |
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline - Cigarettes Per Day | Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks | 30.6 Scores on a scale | Standard Deviation 1.9 |