Cannabis-Tobacco Co-Use Treatment Study
Key facts
- Who runs it
- Medical University of South Carolina
- Where
- Charleston, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 200 people, planned
- Started
- 6 May 2025
- Expected to end
- 1 Jan 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Varenicline
- Counseling
- Psychosocial modules
- Record updated
- 3 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Use of medications with smoking cessation efficacy
- 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
- Pregnant or trying to become pregnant
- Regular use of e-cigarettes or other tobacco products (<10 days in the past month)
Where in United States
- Medical University of South Carolina CharlestonCharleston, United StatesContact: Elizabeth ChapmanTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- VareniclineTreatment being tested
Participants will be randomized 1:1 to varenicline or matched placebo. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1 mg b.i.d. starting on Day 8. Dosing of 2 mg per day will be maintained for the next 11 weeks.
Treatment: Varenicline, Counseling, and Psychosocial modules
- PlaceboPlacebo, for comparison
Participants will be randomized 1:1 to varenicline or matched placebo.
Treatment: Counseling and Psychosocial modules
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)
- Record updated
- 3 April 2026