Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment326 (estimated)
SponsorYale University
Academic / other
Locations2 sites (New Haven, Connecticut and 1 other locations)
StatusRecruiting
StartedOctober 14, 2025
Main results expectedJuly 30, 2030
Study endsOctober 30, 2030
Registry record updatedDecember 17, 2025
Trial IDNCT07040566 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.