NCT07392125

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

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Vaping Cessation

Interventions

Type	Name	Description
DRUG	Cytisinicline	Tablet, 3 times a day (TID), 12 weeks
DRUG	Placebo	Tablet, 3 times a day (TID), 12 weeks
BEHAVIORAL	Behavioral Support	16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period.

Timeline

• Start date: 2026-05-15
• Primary completion: 2026-11-15
• Completion: 2027-09-30
• First posted: 2026-02-06
• Last updated: 2026-02-06

Regulatory

• FDA-regulated drug study