Cannabis-Tobacco Co-Use Treatment Study

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06883162
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cannabis Use
  • Cannabis Use Disorder
  • Marijuana Use
  • Tobacco Use Cessation
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Varenicline — DRUG
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 6, 2025
Status verified
Apr 2026
Primary completion
Sep 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South Carolina - CharlestonCharlestonSouth Carolina29403
Elizabeth Chapman
[email protected]
864-898-2992
Ela Williams
[email protected]

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By research site
Medical University of South Carolina - Charleston· Charleston, SC

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