This phase IV trial tests the effectiveness of counseling in combination with varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of co-use of cigarettes and cannabis (marijuana). Varenicline is a type of nicotine receptor partial agonist and is a drug used to help people stop smoking by acting the same way nicotine acts in the brain. It also reduces the craving and other symptoms associated with withdrawing from nicotine. Varenicline is Food and Drug Administration-approved for smoking cessation but is not approved for the combination treatment of cigarette and cannabis co-use. Varenicline with cessation counseling may help reduce cigarette and cannabis use, even if people are not ready to quit.
Additional locations may be listed on ClinicalTrials.gov for NCT06883162.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Erin A McClure
Phone: 843-792-7192
PRIMARY OBJECTIVES:
I. Evaluate rates of 7-day biochemically confirmed point prevalence abstinence (PPA) from cigarettes at the 12-week end of treatment (EOT) visit comparing varenicline + psychosocial intervention to the placebo + psychosocial intervention participants.
II. Compare reductions in cannabis use frequency and amount between varenicline and placebo groups from the target quit date until EOT (weeks 1-12).
EXPLORATORY OBJECTIVE:
I. Explore differential treatment outcomes for tobacco and cannabis among male versus female participants.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive varenicline orally (PO) once daily (QD) on days 1-3 then twice daily (BID) on days 4-7 of week 1, then BID in weeks 2-12. Participants also receive counseling sessions consisting of discussion of online modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. over 10-15 minutes weekly and review online modules consisting of tobacco, cannabis, and co-use content to support cessation and/or reduction for 12 weeks.
GROUP II: Participants receive placebo PO QD on days 1-3 then BID on days 4-7 of week 1, then BID in weeks 2-12. Participants also counseling sessions consisting of discussion of online modules, while providing skills-based strategies focused on enlisting social support, recognizing triggers, managing craving/withdrawal/stress, etc. over 10-15 minutes weekly and review online modules consisting of tobacco, cannabis, and co-use content to support cessation and/or reduction for 12 weeks.
After completion of study intervention, participants are followed up at 16 and 26 weeks.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorErin A McClure
