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Completed

NCT Number: NCT01292642

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

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.

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Key information

Conditions

Cannabis Dependence Behavior Chemically-Induced Disorders Health Behavior Marijuana Abuse Mental Disorders Nicotine Dependence Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

individual CBT once weekly, 50 minutes, for 10 weeks

Nicotine Replacement Therapy

Drug
  • 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

Other names: Nicotine Transdermal Patch

Primary outcomes

  1. Cigarette Use

    Time frame: Baseline and 10 weeks

    cigarettes per day

  2. Cannabis Use

    Time frame: Baseline and 10 weeks

    cannabis inhalations per day

Secondary outcomes

  1. Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)

Registry information

Acronym: CBT-MJ-NIC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2011
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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