Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alan J. Budney, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01834794
First received: April 15, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Cannabis Dependence;
Behavioral: MET/CBT/CM plus NRT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Tobacco Quit Attempts [ Time Frame: Will be assessed for the duration of study, an average of 16 weeks ] [ Designated as safety issue: No ]
    Sum of 24 hour quit attempts


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Urinalysis tests and self-report data will be collected twice per week during participation in the study


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834794

Contacts
Contact: Alan J Budney, PhD 6036531821 alan.j.budney@dartmouth.edu
Contact: Dustin C Lee, PhD 603-653-1818 Dustin.C.Lee@dartmouth.edu

Locations
United States, New Hampshire
Geisel School of Medicine at Dartmouth; State Building Site Recruiting
Concord, New Hampshire, United States, 03301
Contact: Alan J Budney, PhD    603-653-1821    alan.j.budney@dartmouth.edu   
Principal Investigator: Alan J BUDNEY, PhD         
Geisel School of Medicine at Dartmouth; Rivermill Complex Site Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Alan J Budney, PhD    603-653-1821    Alan.J.Budney@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Responsible Party: Alan J. Budney, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01834794     History of Changes
Other Study ID Numbers: 32243, 1R01DA032243-01
Study First Received: April 15, 2013
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Tobacco Use

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

ClinicalTrials.gov processed this record on October 21, 2014