Recruiting
Phase 3

Varenicline

Sponsor:

Medical University of South Carolina

Code:

NCT06883162

Conditions

Tobacco Use Disorder

Tobacco Use Cessation

Cannabis Use

Cannabis Use Disorder

Marijuana Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Varenicline

Counseling

Psychosocial modules

Study Details

Brief 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.

Conditions

Tobacco Use Disorder

Tobacco Use Cessation

Cannabis Use

Cannabis Use Disorder

Marijuana Use

Study ID

NCT06883162

Start date

May 6, 2025

Status verified date

Apr, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: Placebo

Participants will be randomized 1:1 to varenicline or matched placebo.

Interventions

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.

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.

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.

Primary outcome measure

  • Cigarette abstinence [ Time Frame: Final 7 days of treatment (Week 11 through Week 12) ]

Central Contacts and Locations

Central contacts

Erin Mcclure

843-792-7192mccluree@musc.edu

Elizabeth Chapman

864-898-2992chapmanb@musc.edu

Locations

Medical University of South Carolina - Charleston

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Elizabeth Chapman

864-898-2992chapmanb@musc.edu

Ela Williams

williela@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-03.