Recruiting
Phase 2

Varenicline

Sponsor:

Yale University

Code:

NCT07040566

Conditions

E-cigarette Use

Vaping

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Varenicline 1mg BID

Placebo

Study Details

Brief 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.

Conditions

E-cigarette Use

Vaping

Nicotine Dependence

Study ID

NCT07040566

Start date

Oct 14, 2025

Status verified date

Dec, 2025

Completion date

Oct 30, 2030

Anticipated

Primary completion date

Jul 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

326 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Varenicline

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 comparator: Placebo

Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.

Interventions

Varenicline 1mg BID

12 weeks following the standard titration of 1 mg, twice daily

Placebo

Matching placebo twice daily

Primary outcome measure

  • Number of Participants Abstinent From E-cigarette Use at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Lisa Fucito, PhD

2032001470lisa.fucito@yale.edu

Michael Fatigate, PhD

Michael.fatigate@yale.edu

Locations

Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven

Recruiting

New Haven, Connecticut, United States, 06520

Hollings Cancer Center at MUSC (HCC)

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Yale University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-12-17.