A Trial of Varenicline for E-cigarette Cessation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
report daily use of an e-cigarette containing nicotine
live in Connecticut or South Carolina
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Varenicline 1mg BID
Drug12 weeks following the standard titration of 1 mg, twice daily
Placebo
DrugMatching placebo twice daily
Treatment groups
326 Participants
are divided into 2 treatment groupsGroup A: VareniclineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number 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 12Secondary outcomes
1
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 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov