RECRUITINGPhase 3INTERVENTIONAL

Cannabis-Tobacco Co-Use Treatment Study

Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

Varenicline

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.

BEHAVIORAL

Counseling

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.

BEHAVIORAL

Psychosocial 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.

Locations (1)

Medical University of South Carolina - Charleston

Charleston, South Carolina, United States