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Completed Phase 3 Interventional Results available

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

ClinicalTrials.gov ID: NCT04576949

Public ClinicalTrials.gov record NCT04576949. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.

Study identification

NCT ID
NCT04576949
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Achieve Life Sciences
Industry
Enrollment
810 participants

Conditions and interventions

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 12, 2020
Primary completion
Dec 22, 2021
Completion
Dec 22, 2021
Last update posted
Jan 14, 2026

2020 – 2021

United States locations

U.S. sites
17
U.S. states
17
U.S. cities
17
Facility City State ZIP Site status
Alliance for Multispecialty Research, LLC. Mobile Alabama 36608
Arizona State University Phoenix Arizona 85044
Alliance for Multispecialty Research, LLC Coral Gables Florida 33134
Clinical Research Atlanta Atlanta Georgia 30281
MediSphere Medical Research Center, LLC Evansville Indiana 47714
Alliance for Multispecialty Research, LLC Wichita Kansas 67207
AMR Lexington Lexington Kentucky 40509
Alliance for Multispecialty Research, LLC New Orleans Louisiana 70119
Massachusetts General Hospital - Clinical Genetic Research Facility Boston Massachusetts 02114
Alliance for Multispecialty Research, LLC Kansas City Missouri 64114
Alliance for Multispecialty Research, LLC Las Vegas Nevada 89119
Rochester Clinical Research, Inc. Rochester New York 14609
M3 Wake Research, Inc. Raleigh North Carolina 27612
Coastal Carolina Research Center, Inc. Mt. Pleasant South Carolina 29464
Alliance for Multispecialty Research, LLC. Knoxville Tennessee 37920
FutureSearch Trials of Dallas, LP Dallas Texas 75231
Alliance for Multispecialty Research, LLC Norfolk Virginia 23502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04576949, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 14, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04576949 live on ClinicalTrials.gov.

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