A Trial of Varenicline for E-cigarette Cessation

NCT07040566 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20000385131R01CA296186-01
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Abstinent From E-cigarette Use at 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

  Week 12

Secondary Outcomes (1)

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

  Week 26

Study Arms (2)

Varenicline

EXPERIMENTAL

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.

Drug: Varenicline 1mg BID

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Varenicline 1mg BID DRUG

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

Varenicline

Placebo DRUG

Matching placebo twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• report daily use of an e-cigarette containing nicotine
• live in Connecticut or South Carolina

You may not qualify if:

• regular use of other tobacco products besides e-cigarettes
• medical contraindications for varenicline use
• current treatment for tobacco cessation
• lack proficiency in English

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

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

New Haven, Connecticut, 06520, United States

RECRUITING

Hollings Cancer Center at MUSC (HCC)

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Interventions

Varenicline; BID protein, human

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Benjamin Toll, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Fucito, PhD

CONTACT

2032001470; lisa.fucito@yale.edu

Michael Fatigate, PhD

CONTACT

Michael.fatigate@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adults who report regular e-cigarette use

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): October 30, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Access to the data is managed by the NIMH Data Archive

Locations

US (2)