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Recruiting Phase 3 NCT06883162

Cannabis-Tobacco Co-Use Treatment Study

Trial Parameters

Condition Tobacco Use Disorder
Sponsor Medical University of South Carolina
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-06
Completion 2028-09-01
Interventions
VareniclineCounselingPsychosocial modules

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 (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.

Eligibility Criteria

Inclusion criteria: 1. Ages 18 and over (no upper age limit) 2. Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months 3. Must express interest in quitting tobacco 4. Must express interest in cannabis reduction and/or cessation 5. Must submit a positive instant-read test for cotinine and cannabis prior to enrollment 6. Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days 7. Must be willing to take varenicline or placebo for 12 weeks 8. Must reside in South Carolina Exclusion criteria: 1. 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 2. Pregnant or trying to become pregnant 3. Use of medications with smoking cessation efficacy 4. Regular use of e-cigarettes or other tobacco produ

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