Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

January 11, 2019 updated by: Alan J. Budney, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Geisel School of Medicine at Dartmouth; State Building Site
      • Lebanon, New Hampshire, United States, 03766
        • Geisel School of Medicine at Dartmouth; Rivermill Complex Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco Quit Attempts
Time Frame: Will be assessed for the duration of study, an average of 16 weeks
Sum of 24 hour quit attempts
Will be assessed for the duration of study, an average of 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be assessed twice per week for the duration of the study treatment period, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Alan J Budney, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (ESTIMATE)

April 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32243 D14201
  • 1R01DA032243-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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