Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)
Medical University of South Carolina
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.
Description
Tobacco-cannabis co-use results in established harms, yet there are currently no recommended treatment strategies for co-use. The scientific premise of this proposal is based on work conducted by our group demonstrating that: 1) cannabis co-use adversely impacts cigarette abstinence and those co-using cannabis have nearly double the odds of tobacco treatment failure, 2) varenicline may be efficacious in treating CUD, and 3) cannabis reduction (vs. abstinence) may be a potentially more appealing treatment goal. Therefore, this project proposes to evaluate varenicline versus placebo on cigarette…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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. An…
Interventions
- DrugVarenicline
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.
- BehavioralCounseling
Research staff will provide skills-based counseling at weekly visits. Weekly counseling sessions will include discussion of online intervention modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. Staff will use motivational enhancement techniques to address tobacco cessation, cannabis reduction or abstinence, and medication adherence.
- BehavioralPsychosocial modules
Participants will have access to online modules addressing tobacco and cannabis co-use to support cessation and/or reduction. Content includes 12 virtual modules combining cognitive behavioral therapy (CBT) and motivational enhancement (MET) to address tobacco, cannabis, and their co-use.
Location
- Medical University of South Carolina - CharlestonCharleston, South Carolina