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Clinical Trial Tobacco Marijuana (RCTTM)

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ClinicalTrials.gov Identifier: NCT02277665
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Alan J. Budney, Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:

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.

This protocol reflects the planned Stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets CUD only. 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. 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.


Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Tobacco Use Disorder Behavioral: CUD Treatment Behavioral: Tobacco Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco
Actual Study Start Date : December 18, 2014
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CUD Treatment Only
12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
 Behavioral: CUD Treatment
Other Name: Cognitive Behavioral Therapy and Contingency Management
Experimental: CUD and Tobacco Treatment
12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco
 Behavioral: CUD Treatment
Other Name: Cognitive Behavioral Therapy and Contingency Management

Behavioral: Tobacco Treatment
Other Name: Behavioral Counseling plus NRT


Outcome Measures
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Primary Outcome Measures :
  1. Tobacco Quit Attempts [ Time Frame: Week 12 ]
    Percent of Participants who made at least one tobacco quit attempt

  2. Tobacco Abstinence [ Time Frame: Weeks 9-12 ]
    the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12

  3. Cannabis Abstinence [ Time Frame: Weeks 1-12 ]
    number of participants who achieved at least one week of documented cannabis abstinence during treatment

  4. Weeks of Continuous Cannabis Abstinence [ Time Frame: Weeks 1-12 ]
    Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence

  5. Treatment Attendance [ Time Frame: 12 weeks ]
    Attendance operationalized as the number of clinic visits (urine specimens provided)

  6. Initiation of Nicotine Replacement Therapy (NRT) [ Time Frame: 24 weeks ]
    # of participants who initiated NRT during the 24 week study period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Individuals must be 18 years or older
  2. Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
  3. Individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale)

Exclusion Criteria:

  1. Current dependence on alcohol or any drug other than tobacco and cannabis
  2. Use of non-tobacco nicotine
  3. Current participation in structured treatment for substance abuse
  4. Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder)
  5. Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them
  6. Legal status that would interfere with participation
  7. Living with someone currently enrolled in the project
  8. Not being fluent in English
  9. Not living within 45 miles of the research site
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02277665


Locations
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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
United States, Washington
University of Washington School of Social Work
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Alan J Budney, Ph.D Dartmouth-Hitchcock Medical Center
Principal Investigator: Denise Walker, Ph.D University of Washington School of Social Work
  Study Documents (Full-Text)

Documents provided by Alan J. Budney, Dartmouth-Hitchcock Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 1, 2018

More Information
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Responsible Party: Alan J. Budney, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02277665    
Other Study ID Numbers: STUDY00028307 D14233
5R01DA032243 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2014    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018
Keywords provided by Alan J. Budney, Dartmouth-Hitchcock Medical Center:
Cannabis Use Disorder
Tobacco Use
Treatment
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Tobacco Use Disorder
Pathologic Processes
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders