NCT06883162 Cannabis-Tobacco Co-Use Treatment Study
| NCT ID | NCT06883162 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Medical University of South Carolina |
| Condition | Tobacco Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-05-06 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 products (\<10 days in the past month)
Contact & Investigator
Erin Mcclure
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06883162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06883162 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06883162 currently recruiting?
Yes, NCT06883162 is actively recruiting participants. Contact the research team at mccluree@musc.edu for enrollment information.
Where is the NCT06883162 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06883162 clinical trial?
NCT06883162 is sponsored by Medical University of South Carolina. The principal investigator is Erin Mcclure at Medical University of South Carolina. The trial plans to enroll 200 participants.