Clinical Trial Tobacco Marijuana (RCTTM)

Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Cannabis Use Disorder
• Intervention / Treatment: Behavioral: CUD Treatment; Behavioral: Tobacco Treatment

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

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
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Cognitive Behavioral Therapy and Contingency Management; Behavioral: Tobacco Treatment; Other Names: Behavioral Counseling plus NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Quit Attempts	Percent of Participants who made at least one tobacco quit attempt	Week 12
Tobacco Abstinence	the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12	Weeks 9-12
Cannabis Abstinence	number of participants who achieved at least one week of documented cannabis abstinence during treatment	Weeks 1-12
Weeks of Continuous Cannabis Abstinence	Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence	Weeks 1-12
Treatment Attendance	Attendance operationalized as the number of clinic visits (urine specimens provided)	12 weeks
Initiation of Nicotine Replacement Therapy (NRT)	# of participants who initiated NRT during the 24 week study period	24 weeks

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): December 18, 2014
• Primary Completion (Actual): January 18, 2017
• Study Completion (Actual): January 18, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Treatment; Tobacco Use; Cannabis Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Tobacco Use Disorder; Marijuana Abuse
• Other Study ID Numbers: STUDY00028307 D14233; 5R01DA032243 (U.S. NIH Grant/Contract)