Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
326 participants
INTERVENTIONAL
2025-10-14
2030-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Varenicline 1mg BID
12 weeks following the standard titration of 1 mg, twice daily
Placebo
Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.
Placebo
Matching placebo twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Varenicline 1mg BID
12 weeks following the standard titration of 1 mg, twice daily
Placebo
Matching placebo twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* live in Connecticut or South Carolina
Exclusion Criteria
* medical contraindications for varenicline use
* current treatment for tobacco cessation
* lack proficiency in English
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lisa Fucito, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Benjamin Toll, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000038513
Identifier Type: -
Identifier Source: org_study_id