A Trial of Varenicline for E-cigarette Cessation

NCT07040566 — Phase 2, Recruiting, 326 participants, Yale University

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Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults

Registry	NCT07040566
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	326 (Estimated)
Sponsor	Yale University (Other); collaborators: National Cancer Institute (NCI)
Conditions	E-cigarette Use, Vaping, Nicotine Dependence
Interventions	Varenicline 1mg BID, Placebo (Drug)
Dates	start 2025-10-14, primary completion 2030-07-30 (estimated), completion 2030-10-30 (estimated), first posted 2025-06-27, last updated 2025-12-17
Locations	2 sites in United States

-Summary

This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.

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+Detailed description

Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.

The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.

+Arms and interventions

Arm	Type	Interventions	Description
Varenicline	Experimental	Drug: Varenicline 1mg BID	Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources.
Placebo	Placebo comparator	Drug: Placebo	Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.

Varenicline 1mg BID (Drug): 12 weeks following the standard titration of 1 mg, twice daily
Placebo (Drug): Matching placebo twice daily

+Outcome measures

Primary outcomes

Number of Participants Abstinent From E-cigarette Use at Week 12 [Week 12]: 7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine

Secondary outcomes

Number of Participants Abstinent From E-cigarette Use at Week 26 [Week 26]: 7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
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

+Investigators

Lisa Fucito, PhD, Principal investigator, Yale University
Benjamin Toll, PhD, Principal investigator, Medical University of South Carolina

+Funding

NIH grants: R01CA296186