Status:
RECRUITING
Cannabis-Tobacco Co-Use Treatment Study
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Tobacco Use Disorder
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (...
Detailed Description
Tobacco-cannabis co-use results in established harms, yet there are currently no recommended treatment strategies for co-use. The scientific premise of this proposal is based on work conducted by our ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Ages 18 and over (no upper age limit)
- Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
- Must express interest in quitting tobacco
- Must express interest in cannabis reduction and/or cessation
- Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
- Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
- Must be willing to take varenicline or placebo for 12 weeks
- Must reside in South Carolina
- Exclusion criteria:
- Any significant or acutely unstable medical, psychiatric, or substance use problem (including clinically significant disorders) that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
- Pregnant or trying to become pregnant
- Use of medications with smoking cessation efficacy
- Regular use of e-cigarettes or other tobacco products (\<10 days in the past month)
- Self-reported use of cannabis exclusively for medical purposes
Exclusion
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06883162
Start Date
May 6 2025
End Date
January 1 2029
Last Update
May 8 2025
Active Locations (1)
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1
Medical University of South Carolina - Charleston
Charleston, South Carolina, United States, 29403