Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
CBT-MJ-NIC
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 14, 2013
CompletedAugust 14, 2013
August 1, 2013
1.8 years
February 8, 2011
June 25, 2013
August 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cigarette Use
cigarettes per day
Baseline and 10 weeks
Cannabis Use
cannabis inhalations per day
Baseline and 10 weeks
Secondary Outcomes (1)
Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks
10 weeks
Study Arms (1)
Treatment
EXPERIMENTALCognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
- Harvard Medical School (HMS and HSDM)collaborator
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Related Publications (3)
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. doi: 10.1037/0022-006X.72.3.455.
PMID: 15279529BACKGROUNDHill, 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.
BACKGROUNDHall SM, Munoz RF, Reus VI. Cognitive-behavioral intervention increases abstinence rates for depressive-history smokers. J Consult Clin Psychol. 1994 Feb;62(1):141-6. doi: 10.1037//0022-006x.62.1.141.
PMID: 8034816BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
slightly more than one-third of participants did not complete treatment. The small sample size and relatively high proportion of treatment non-completers may limit our interpretation of the results.
Results Point of Contact
- Title
- Kevin P Hill, MD, MHS
- Organization
- McLean Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin P Hill, MD, MHS
Mclean Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Psychiatry
Study Record Dates
First Submitted
February 8, 2011
First Posted
February 9, 2011
Study Start
August 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 14, 2013
Results First Posted
August 14, 2013
Record last verified: 2013-08