A Trial of Varenicline for E-cigarette Cessation
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07040566
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- E-cigarette Use
- Nicotine Dependence
- Vaping
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Varenicline 1mg BID — DRUG12 weeks following the standard titration of 1 mg, twice daily
- Placebo — DRUGMatching placebo twice daily
Study Details
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.
Key Dates
- Start date
- Oct 14, 2025
- Status verified
- Dec 2025
- Primary completion
- Jul 30, 2030
- Completion
- Oct 30, 2030
Study Design
- Enrollment
- 326 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VareniclineParticipants 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 Comparator: PlaceboParticipants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources.
Primary Outcome Measure
Number of Participants Abstinent From E-cigarette Use at Week 12 [ Time Frame: Week 12 ]
Central Contacts
- Lisa Fucito, PhD2032001470
- Michael Fatigate, PhD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06520 | - |
| Hollings Cancer Center at MUSC (HCC) | Charleston | South Carolina | 29425 | - |
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