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

This study has been completed.
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01292642
First received: February 8, 2011
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a 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 transdermal nicotine treatment, will reduce the use of marijuana and nicotine.


Condition Intervention Phase
Cannabis Dependence
Nicotine Dependence
 Behavioral: Cognitive Behavioral Therapy
Drug: nicotine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Cigarette use [ Time Frame: August 2009-June 2011 ] [ Designated as safety issue: No ]
    Number of cigarettes smoked per day per self-report

  • cannabis use [ Time Frame: August 2009-June 2011 ] [ Designated as safety issue: No ]
    number of cannabis hits per day based upon self-report


Secondary Outcome Measures:
  • study completion rate [ Time Frame: August 2009-June 2011 ] [ Designated as safety issue: No ]
    number of subjects completing study of those enrolled

  • client satisfaction [ Time Frame: August 2009-June 2011 ] [ Designated as safety issue: No ]
    scores on the Client Satisfaction Questionnaire (CSQ-8)at baseline, 4, 6, 8, and 10 weeks


Enrollment: 12
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
CBT plus NRT
 Behavioral: Cognitive Behavioral Therapy
individual CBT once weekly, 50 minutes, for 10 weeks
Drug: nicotine
  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

Detailed Description:

The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a CBT intervention. (FIGURE 1) Twelve subjects (50% female, ages 18-65) who meet 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 transdermal nicotine treatment. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292642

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Harvard University
Investigators
Principal Investigator: Kevin P Hill, MD, MHS Mclean Hospital
  More Information

Publications:

Responsible Party: Kevin P. Hill, MD, MHS, Instructor in Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01292642     History of Changes
Other Study ID Numbers: 2008-P-000927
Study First Received: February 8, 2011
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
cognitive behavioral therapy
nicotine dependence
cannabis dependence
smoking cessation
nicotine replacement therapy

Additional relevant MeSH terms:
Marijuana Abuse
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013