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 Medical School
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01292642
First received: February 8, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Cannabis Dependence
Nicotine Dependence
Behavioral: Cognitive Behavioral Therapy
Drug: Nicotine Replacement Therapy
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:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Cigarette Use [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    cigarettes per day

  • Cannabis Use [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    cannabis inhalations per day


Secondary Outcome Measures:
  • Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


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
Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
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
Other Name: Nicotine Transdermal Patch

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical School
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
Results First Received: June 25, 2013
Last Updated: August 13, 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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014