Varenicline to help adults stop vaping
Official title: Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
Run by Yale University · NCT07040566 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Status | Recruiting |
| Started | October 14, 2025 |
| Main results expected | July 30, 2030 |
| Study ends | October 30, 2030 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07040566 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Varenicline is well supported for cigarette smoking cessation, but there are few placebo-controlled trials specifically testing it for e-cigarette cessation.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
TUBSIS 2.0 — an online program to help adults reduce or quit smoking and vaping
This program tests whether a free, anonymous, 4-week web-based course using mindfulness, self-compassion, and behavior-change techniques helps German-, English-, and Turkish-speaking adults who smoke or vape reduce or quit tobacco.
-
Social media support groups to help teens and young adults quit vaping
This pilot tries a social-media group program called the Quit the Hit Toolkit to help adolescents and young adults who vape stop using nicotine.
-
Sex differences in how menthol e-cigarettes appeal to people who smoke
This study tests whether men and women differ in how menthol e-cigarettes with or without nicotine appeal to smokers who have used e-cigarettes before.
-
Varenicline plus enhanced TMS to help adults quit smoking and vaping
This study tests whether adding active enhanced accelerated transcranial magnetic stimulation (aTMS) to varenicline helps adults 18–65 quit nicotine use more effectively than varenicline with sham stimulation.
-
QuitVaping behavioral program with texting support to help teens stop vaping
This trial will try QuitVaping plus extra texting to see if it helps teens aged 14–18 who vape nicotine quit more than standard education and referral alone.
-
Smoky Futures: Danish Adolescent Nicotine Use over Time
This observational cohort follows Danish youths ages 15–25 to see how cigarette, e-cigarette, and other nicotine use begin, change, and affect health and education over several years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.