RecruitingPhase 3

Cannabis-Tobacco Co-Use Treatment Study

United States200 participantsStarted 2025-05-06

Plain-language 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 (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Cigarette abstinence

Timeframe: Final 7 days of treatment (Week 11 through Week 12)

Trial details

NCT IDNCT06883162

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Erin Mcclure

843-792-7192 mccluree@musc.edu

View on ClinicalTrials.gov More Tobacco Use Disorder trials