NCT07040566

A Trial of Varenicline for E-cigarette Cessation

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• E-cigarette Use
• Vaping
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Varenicline 1mg BID	12 weeks following the standard titration of 1 mg, twice daily
DRUG	Placebo	Matching placebo twice daily

Timeline

• Start date: 2025-10-14
• Primary completion: 2030-07-30
• Completion: 2030-10-30
• First posted: 2025-06-27
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study