Varenicline to help adults stop vaping
Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
This trial tests whether the smoking-cessation pill varenicline helps adults who vape daily quit e-cigarettes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT07040566 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 2 trial in adults seeking help to stop regular e-cigarette use. Participants are randomly assigned to 12 weeks of varenicline (titrated to 2 mg daily) or matching placebo, plus brief counseling and self-management resources. Research visits occur every three weeks during treatment with a final follow-up at week 26 to measure quit rates and changes in health biomarkers. The study also looks at predictors and moderators of who benefits most from treatment.
Who should consider this trial
Good fit: Adults who use nicotine-containing e-cigarettes daily, are seeking cessation help, live in Connecticut or South Carolina, speak English, and have no medical contraindication to varenicline are ideal candidates.
Not a fit: People who regularly use other tobacco products, are already in tobacco cessation treatment, have medical contraindications to varenicline, or do not live near the study sites are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the trial could establish varenicline as an effective medication to help people stop using e-cigarettes and reduce nicotine dependence.
How similar studies have performed: Varenicline is well supported for cigarette smoking cessation, but there are few placebo-controlled trials specifically testing it for e-cigarette cessation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * report daily use of an e-cigarette containing nicotine * live in Connecticut or South Carolina Exclusion Criteria: * regular use of other tobacco products besides e-cigarettes * medical contraindications for varenicline use * current treatment for tobacco cessation * lack proficiency in English
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States (Recruiting)
- Hollings Cancer Center at MUSC (HCC) — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Fucito, PhD — Yale University
- Study coordinator: Lisa Fucito, PhD
- Email: lisa.fucito@yale.edu
- Phone: 2032001470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.