NCT05431387

A Study of Cytisinicline for Vaping Cessation in Adult Smokers

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adults Using Nicotine-containing E-cigarettes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.

Conditions

• Vaping
• E-Cig Use

Interventions

Type	Name	Description
DRUG	cytisinicline	film-coated oral tablets containing 3 mg cytisinicline
DRUG	Placebo	film-coated oral tablets containing matched placebo
BEHAVIORAL	Behavioral support	Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the participant about their attempt to quit vaping. Each session will last approximately 10 minutes.

Timeline

• Start date: 2022-07-13
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-06-24
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study