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 — DRUG
    12 weeks following the standard titration of 1 mg, twice daily
  • Placebo — DRUG
    Matching 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: 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.
  • Placebo Comparator: 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 Measure

Number of Participants Abstinent From E-cigarette Use at Week 12 [ Time Frame: Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer Center/Smilow Cancer Hospital at Yale-New HavenNew HavenConnecticut06520-
Hollings Cancer Center at MUSC (HCC)CharlestonSouth Carolina29425-

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