A Trial of Varenicline for E-cigarette Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Varenicline 1mg BID, Placebo.
- Who it may be relevant to
- Registry conditions: E-cigarette Use, Vaping, Nicotine Dependence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
Overview
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
- Drug Varenicline 1mg BID
12 weeks following the standard titration of 1 mg, twice daily - Drug Placebo
Matching placebo twice daily
Primary outcome measures
- Number of Participants Abstinent From E-cigarette Use at Week 12 [Time frame: Week 12]
Secondary outcome measures (1)
- Number of Participants Abstinent From E-cigarette Use at Week 26 [Time frame: Week 26]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven — New Haven
- Hollings Cancer Center at MUSC (HCC) — Charleston
Identifiers
NCT: NCT07040566 · 2000038513 · 1R01CA296186-01