A Randomized, Controlled Trial of Varenicline for E-cigarette Cessation

Not Applicable

Not yet recruiting

• Conditions: E-cigarette Use; Vaping; Nicotine Dependence
• Interventions: Drug: Varenicline 1mg BID; Drug: Placebo

• Registration Number: NCT07040566
• Lead Sponsor: Yale University

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.

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-01
• Primary Completion: 2029-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 326

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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

Hollings Cancer Center at MUSC (HCC); 🇺🇸 Charleston, South Carolina, United States