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Varenicline for Tobacco and Cannabis Co-Use (RECLAIM)
NCT06883162Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2025
- Primary completion
- Sep 2028
- Countries
- 1
- Sponsor
- Medical University of South Carolina
- Modality
- Small Molecules
- Drugs
- varenicline
- Conditions
- Tobacco Use Disorder (TUD)cannabis use disorder (CUD)
01
Overview
Phase 3, randomised, double-blind trial in Tobacco Use Disorder (TUD) and cannabis use disorder (CUD) comparing Varenicline with Placebo (2 arms). Primary endpoint: 7-day biochemically confirmed point prevalence abstinence from cigarettes at 12 weeks. Started May 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Varenicline
Varenicline (titrated to 2 mg/day) + Psychosocial intervention
Placebo
Matched placebo + Psychosocial intervention
03
Who it enrols
Adults residing in South Carolina who co-use cigarettes and cannabis regularly, are interested in quitting/reducing both, and have no unstable medical or psychiatric conditions.
04
Endpoints
Primary
7-day biochemically confirmed point prevalence abstinence from cigarettes
Secondary
Changes in cannabis use frequency
Changes in cannabis use amount
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