Cannabis-Tobacco Co-Use Treatment Study

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 6, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

January 1, 2029

Conditions
Tobacco Use DisorderTobacco Use CessationCannabis UseCannabis Use DisorderMarijuana Use
Interventions
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.

Trial Locations (1)

29403

RECRUITING

Medical University of South Carolina - Charleston, Charleston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Medical University of South Carolina

OTHER