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Cannabis-Tobacco Co-Use Treatment Study

RecruitingPhase 3Healthy volunteers welcome

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full 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)

About the study

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.

What is being tested

Sponsor: Medical University of South Carolina · Participants: 200 · Started: May 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06883162

Locations in the U.S.

South CarolinaMedical University of South Carolina - Charleston, Charleston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.