A Trial of Varenicline for E-cigarette Cessation
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- report daily use of an e-cigarette containing nicotine
- live in Connecticut or South Carolina
Exclusion criteria
- regular use of other tobacco products besides e-cigarettes
- medical contraindications for varenicline use
- current treatment for tobacco cessation
- lack proficiency in English
Trial design
Primary purpose
Allocation
Interventional model
Masking
326 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Michael Fatigate, PhD; Lisa Fucito, PhD
Data sourced from clinicaltrials.gov
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