Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01834794
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : April 3, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Alan J. Budney, Dartmouth-Hitchcock Medical Center

Brief Summary:
This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and increases adverse acute and long-term psychosocial and health consequences. The proposed treatment will integrate existing computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement medications to improve outcomes in this difficult to treat clinical population.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Behavioral: MET/CBT/CM plus NRT Not Applicable

Detailed Description:
Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes. A two-phase, Stage 1 therapy development project will accomplish the following: First, a treatment protocol and manual will be developed that integrates a tailored intervention for tobacco smoking with an intervention for CUD (Aim 1). Utilization of web-based counseling programs will standardize delivery of the intervention and foster eventual dissemination. A pilot study will provide an initial test of acceptability and feasibility. Second, a Stage 1, proof-of-concept study will compare this intervention to one that targets CUD only (Aim 2). The hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts (Aim 3). If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
Study Start Date : March 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: MET/CBT/CM plus NRT

Motivational Enhancement Therapy, Cognitive Behavior Therapy, Contingency Management plus Nicotine Replacement Therapy (MET/CBT/CM) + NRT

Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.

Behavioral: MET/CBT/CM plus NRT
Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.

Primary Outcome Measures :
  1. Tobacco Quit Attempts [ Time Frame: Will be assessed for the duration of study, an average of 16 weeks ]
    Sum of 24 hour quit attempts

Secondary Outcome Measures :
  1. Cannabis Abstinence: continuous weeks of abstinence achieved during the 12 week treatment period [ Time Frame: Will be assessed twice per week for the duration of the study treatment period, 12 weeks ]
    Urinalysis tests and self-report data will be collected twice per week during participation in the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-65 years old
  • current DSM-IV diagnosis of cannabis abuse or dependence
  • report use of cannabis on at least 45 of previous 90 days
  • report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
  • some indication of interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale

Exclusion Criteria:

  • current dependence on alcohol or any drug other than tobacco and cannabis
  • active or recent suicidal ideation
  • use of non-tobacco nicotine
  • current participation in treatment for substance abuse
  • severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder).
  • a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack
  • legal status that would interfere with participation
  • living with someone enrolled in the project
  • not living within 30 miles of the research site (unless an exception is authorized by the PI)
  • not being fluent in english

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01834794

United States, New Hampshire
Geisel School of Medicine at Dartmouth; State Building Site
Concord, New Hampshire, United States, 03301
Geisel School of Medicine at Dartmouth; Rivermill Complex Site
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: Alan J Budney Dartmouth-Hitchcock Medical Center

Publications of Results:
Responsible Party: Alan J. Budney, Professor, Dartmouth-Hitchcock Medical Center Identifier: NCT01834794     History of Changes
Other Study ID Numbers: 32243
1R01DA032243-01 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Keywords provided by Alan J. Budney, Dartmouth-Hitchcock Medical Center:
Tobacco Use

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders