Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence (CBT-MJ-NIC)

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Cannabis Dependence; Nicotine Dependence

Treatments: Behavioral: Cognitive Behavioral Therapy; Drug: Nicotine Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01292642

2008-P-000927

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment

Experimental group

Description:

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:

Behavioral: Cognitive Behavioral Therapy

Drug: Nicotine Replacement Therapy