Clinical Trial

Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

Study acronym: ORCA-V2
Not Yet Recruiting Phase 3
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Summary
This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only. A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms: * Arm B, 12 weeks cytisinicline + behavior support: N=400 or * Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).
Trial Details
NCT Number NCT07392125
Lead Sponsor Achieve Life Sciences
Conditions Vaping Cessation
Enrollment 800 participants
Start Date 2026-05-15
Primary Completion 2026-11-15 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-06