CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
cytisinicline +2 moredrug
Likely dose
cytisinicline 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05431387
NCT05431387Phase 2Completed
CompareCT.gov

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

Achieve Life Sciences·interventional·Posted Jun 24, 2022·Updated Jan 14, 2026

In Brief

A Phase 2 clinical trial evaluating cytisinicline, Placebo, and 1 other intervention for Vaping and E-Cig Use. Completed, enrolled 160 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaping, E-Cig Use
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJun 24, 2022
Enrollment StartJul 13, 2022
Primary CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.0 years ago

Interventions

cytisiniclinedrug

film-coated oral tablets containing 3 mg cytisinicline

Placebodrug

film-coated oral tablets containing matched placebo

Behavioral supportbehavioral

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.