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

Nicotine Dependence Clinical Trial

— CBT-MJ-NIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292642
• Other study ID #: 2008-P-000927
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2011
• Last updated: August 13, 2013
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2013
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy
individual CBT once weekly, 50 minutes, for 10 weeks

Drug:
• Nicotine Replacement Therapy
21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks 14 m g patch for 8 weeks, then 7 mg patch for 2 weeks

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Harvard Medical School

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hall SM, Muñoz RF, Reus VI. Cognitive-behavioral intervention increases abstinence rates for depressive-history smokers. J Consult Clin Psychol. 1994 Feb;62(1):141-6. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette Use	cigarettes per day	Baseline and 10 weeks	No
Primary	Cannabis Use	cannabis inhalations per day	Baseline and 10 weeks	No
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.	10 weeks	No