Actively Recruiting
A Prospective Trial of Varenicline and Incentives for E-cigarette Cessation in Adults Who Co-use Cannabis
Led by Medical University of South Carolina · Updated on 2025-07-07
105
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand tobacco cessation outcomes among adults aged 18 to 40 who use both e-cigarettes and cannabis. It evaluates the use of varenicline, a medication approved for cigarette cessation but not e-cigarette cessation, alongside financial incentives to support quitting e-cigarettes. The study also explores how cannabis and tobacco use interact during an attempt to stop using e-cigarettes, addressing gaps in current knowledge about co-use impacts on quitting success. Participants will receive 12 weeks of e-cigarette cessation treatment, including varenicline with a standard dosing schedule starting at 0.5 mg once daily and increasing to 1.0 mg twice daily, maintained for 12 weeks. Behavioral interventions include contingency management with weekly financial incentives of $20 for biochemically verified abstinence, and psychosocial counseling throughout the study. All participants receive active medication and support without placebo comparison. During the study, participants will attend weekly visits for counseling and urine testing to verify abstinence from e-cigarettes through cotinine levels. Researchers will measure 7-day tobacco abstinence at Week 12 and track changes in cannabis use during the final 4 weeks of treatment. The study also assesses the effect of cannabis use severity on quitting success. Participation includes biochemical tests, counseling sessions, and financial incentives over a 12-week treatment period.
CONDITIONS
Brief Title
E-cigarette Cessation in Adults Who Co-use Cannabis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 40 years old
- Use e-cigarettes daily or near daily in the past month
- Submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)
- Interested in quitting use of e-cigarettes
- Willing to take varenicline for the standard 12-week course of treatment
- Self-reported use of cannabis on at least 10 out of the past 30 days or submit a positive qualitative urinary cannabinoid test at screening (> 50 ng/ml)
You will not qualify if you...
- Any serious or unstable medical or psychiatric disorder in the past three months that may interfere with study performance
- Use of cigarettes on 10 or more days in the past 30
- Currently pregnant or breastfeeding
- Current use of medications with smoking cessation efficacy
- Use of any medications that would interfere with varenicline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive varenicline medication along with psychosocial counseling and contingency management with financial incentives to support e-cigarette cessation.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 3 locations
1
MUSC Charleston
Charleston, South Carolina, United States, 29425
Actively Recruiting
2
MUSC Lancaster
Lancaster, South Carolina, United States, 29720
Actively Recruiting
3
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
Actively Recruiting
Research Team
E
Elizabeth Chapman, MA, LPC, LAC, AADC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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