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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
326
12 weeks following the standard titration of 1 mg, twice daily
Matching placebo twice daily
Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
RECRUITINGHollings Cancer Center at MUSC (HCC)
Charleston, South Carolina, United States
RECRUITINGNumber of Participants Abstinent From E-cigarette Use at 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
Time frame: Week 12
Number of Participants Abstinent From E-cigarette Use at 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
Time frame: Week 26
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