Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

Phase 2

Completed

Interventions: Behavioral: Cognitive Behavioral Therapy
Drug: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Nicotine Replacement Therapy	Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Treatment	Cognitive Behavioral Therapy	Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.

Primary Outcome Measures

Name	Time	Method
Cigarette Use	Baseline and 10 weeks	cigarettes per day
Cannabis Use	Baseline and 10 weeks	cannabis inhalations per day

Secondary Outcome Measures

Name	Time	Method
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.