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

Primary Purpose

Cannabis Dependence, Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Nicotine Replacement Therapy
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring cognitive behavioral therapy, nicotine dependence, cannabis dependence, smoking cessation, nicotine replacement therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Cigarette Use
cigarettes per day
Cannabis Use
cannabis inhalations per day

Secondary Outcome Measures

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.

Full Information

First Posted
February 8, 2011
Last Updated
August 13, 2013
Sponsor
Mclean Hospital
Collaborators
Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT01292642
Brief Title
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Acronym
CBT-MJ-NIC
Official Title
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Harvard Medical School (HMS and HSDM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Nicotine Dependence
Keywords
cognitive behavioral therapy, nicotine dependence, cannabis dependence, smoking cessation, nicotine replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
individual CBT once weekly, 50 minutes, for 10 weeks
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy
Other Intervention Name(s)
Nicotine Transdermal Patch
Intervention Description
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
Primary Outcome Measure Information:
Title
Cigarette Use
Description
cigarettes per day
Time Frame
Baseline and 10 weeks
Title
Cannabis Use
Description
cannabis inhalations per day
Time Frame
Baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin P Hill, MD, MHS
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15279529
Citation
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.
Results Reference
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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.
Results Reference
background
PubMed Identifier
8034816
Citation
Hall 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.
Results Reference
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Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

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