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NCT Number: NCT07040566

A Trial of Varenicline for E-cigarette Cessation

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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Key information

Conditions

E-cigarette Use Behavior Chemically-Induced Disorders Mental Disorders Nicotine Dependence Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline 1mg BID

Drug

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

Placebo

Drug

Matching placebo twice daily

Primary outcomes

  1. Number of Participants Abstinent From E-cigarette Use at Week 12

    Time frame: 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

  1. Number of Participants Abstinent From E-cigarette Use at Week 26

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Fucito, PhD

CONTACT

[email protected]

2032001470

Michael Fatigate, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 27, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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