Clinical Trial Tobacco Marijuana

Tobacco Use Disorder Clinical Trial

— RCTTM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277665
• Other study ID #: STUDY00028307 D14233
• Secondary ID: 5R01DA032243
• Status: Completed
• Phase: N/A
• Start date: December 18, 2014
• Est. completion date: January 18, 2017

Study information

• Verified date: December 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Disease
• Marijuana Abuse
• Tobacco Use Disorder

Intervention

Behavioral:
• CUD Treatment

• Tobacco Treatment

Locations

Country	Name	City	State
United States	Geisel School of Medicine at Dartmouth; State Building Site	Concord	New Hampshire
United States	Geisel School of Medicine at Dartmouth; Rivermill Complex Site	Lebanon	New Hampshire
United States	University of Washington School of Social Work	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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