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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 Oct 21, 2026, 12:16 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 13, 2020 (Actual)
Primary completion
Dec 23, 2021 (Actual)
Completion
Dec 23, 2021 (Actual)
Last update posted
Jan 15, 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 15, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04576949 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →