This phase IV trial studies how well varenicline works together with financial incentives to help people who also use cannabis quit smoking electronic (e)-cigarettes. Researchers are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt (cessation). Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the United States. Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. 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. Varenicline is not approved by the Food and Drug Administration (FDA) for e-cigarette cessation, but is FDA approved for cigarette cessation. Giving varenicline together with financial incentives may work better at helping people who co-use cannabis quit smoking e-cigarettes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06688539.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Erin A McClure
Phone: 843-792-7192
Lancaster
MUSC Health Lancaster Medical CenterStatus: Active
Contact: Erin A McClure
Phone: 843-792-7192
PRIMARY OBJECTIVES:
I. To compare rates of 7-day biochemically-confirmed e-cigarette abstinence with cigarette abstinence rates from the parent R37 co-use sample (as a historical controls).
II. To assess changes in cannabis use during e-cigarette cessation treatment among the new sample of participants enrolled in this extension.
III. To assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation.
IV. To characterize and compare patterns of co-use among the e-cigarette sample to those using cigarettes (parent R37).
OUTLINE:
Beginning on day -7, patients undergo e-cigarette counseling over 5-10 minutes and receive training videos delivered to their smartphone twice daily (BID) on how to upload videos of themselves taking their medication to prepare for day 0 (quit day) of study. Patients receive varenicline orally (PO) once daily on days 1-3 then BID for 12 weeks on study in the absence of disease progression or unacceptable toxicity. Patients upload videos of themselves taking their medication BID, participate in counseling sessions over 5-10 minutes once a week (QW) for 12 weeks, and receive financial incentives based on tobacco abstinence QW during weeks 2-12 on study. Patients also receive daily text message reminders to upload their videos beginning on day -7 for 13 weeks. Additionally, patients undergo urine sample collection and carbon monoxide breath tests throughout the study.
After completion of study intervention, patients are followed up at week 16 and at week 26.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorErin A McClure
