E-cigarette Use, Nicotine Dependence, Vaping
Conditions
Brief summary
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.
Detailed 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.
Interventions
12 weeks following the standard titration of 1 mg, twice daily
DRUGPlacebo
Matching placebo twice daily
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Adults who report regular e-cigarette use
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Abstinent From E-cigarette Use at Week 12 | Week 12 | 7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Abstinent From E-cigarette Use at Week 26 | Week 26 | 7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine |
Countries
United States
Contacts
Primary ContactLisa Fucito, PhD
Backup ContactMichael Fatigate, PhD
Outcome results
None listed