Treatment for quitting cigarettes and reducing cannabis use
Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)
This study tests if a medication called varenicline can help adults who smoke cigarettes and use cannabis quit smoking and cut down on cannabis use, with support from counseling and online resources.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06883162 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of varenicline, a medication typically used for smoking cessation, compared to a placebo in adults who co-use cigarettes and cannabis. Participants will receive counseling and access to online treatment modules to support their quit attempts for cigarettes and reduction attempts for cannabis. The study is conducted remotely, requiring no in-person visits, and aims to address the lack of treatment strategies for individuals who use both substances. The research is based on previous findings that highlight the challenges of co-use and the potential benefits of varenicline for both tobacco and cannabis use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older living in South Carolina who smoke at least 5 cigarettes per day and use cannabis regularly.
Not a fit: Patients with significant medical or psychiatric issues, pregnant individuals, or those using medications for smoking cessation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cessation rates for tobacco and reduce cannabis use among co-users.
How similar studies have performed: While varenicline has shown efficacy for tobacco cessation, this specific approach for co-use of tobacco and cannabis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina - Charleston — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Erin Mcclure — Medical University of South Carolina
- Study coordinator: Erin Mcclure
- Email: mccluree@musc.edu
- Phone: 843-792-7192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.