Actively Recruiting
Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
Led by Yale University · Updated on 2025-12-17
326
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of varenicline, compared to a placebo, for helping adults who regularly use e-cigarettes to quit. This phase 2 randomized, placebo-controlled trial focuses on treatment-seeking adults who report daily e-cigarette use, aiming to understand if varenicline can increase quit rates and how quitting affects health-related biomarkers. Participants will be randomly assigned to one of two groups: one group will receive varenicline titrated to 2 mg daily over 12 weeks along with brief counseling and self-management resources, while the other group will receive a matching placebo with the same counseling and resources. Assessments will occur every 3 weeks during the treatment period, with a final follow-up at week 26. Throughout the study, participants will complete evaluations every three weeks and a final visit at 26 weeks to measure abstinence from e-cigarette use and assess changes in health biomarkers related to cessation. The primary outcome is the number of participants abstinent at week 12, with additional outcomes measured at week 26. The study includes monitoring for safety and treatment adherence over the 26-week period.
CONDITIONS
Brief Title
A Trial of Varenicline for E-cigarette Cessation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Report daily use of an e-cigarette containing nicotine
- Live in Connecticut or South Carolina
- Be 18 years of age or older
You will not qualify if you...
- Regular use of other tobacco products besides e-cigarettes
- Medical contraindications for varenicline use
- Current treatment for tobacco cessation
- Lack proficiency in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 12 weeks of varenicline or placebo along with brief cessation advice and self-management resources.
Research assessments every 3 weeks during treatment
Duration - Week 13 to Week 26
Participants complete a final follow-up visit to assess abstinence from e-cigarette use.
1 visit at Week 26
Trial Site Locations
Total: 2 locations
1
Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Hollings Cancer Center at MUSC (HCC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
L
Lisa Fucito, PhD
M
Michael Fatigate, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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