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

NCT ID: NCT01292642

Last Updated: 2013-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Cannabis Dependence Nicotine Dependence

Keywords

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cognitive behavioral therapy nicotine dependence cannabis dependence smoking cessation nicotine replacement therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

individual CBT once weekly, 50 minutes, for 10 weeks

Nicotine Replacement Therapy

Intervention Type DRUG

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

Interventions

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Cognitive Behavioral Therapy

individual CBT once weekly, 50 minutes, for 10 weeks

Intervention Type BEHAVIORAL

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

Intervention Type DRUG

Other Intervention Names

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Nicotine Transdermal Patch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kevin P. Hill, MD, MHS

Instructor in Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin P Hill, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15279529 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 8034816 (View on PubMed)

Other Identifiers

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2008-P-000927

Identifier Type: -

Identifier Source: org_study_id