NCT01292642

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mclean Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cannabis Dependence
• Nicotine Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	individual CBT once weekly, 50 minutes, for 10 weeks
DRUG	Nicotine 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

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-09
• Last updated: 2013-08-14
• Results posted: 2013-08-14

Locations

1 site across 1 country: United States