Clinical trialNCT04576949CompletedPhase 3Interventional

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

SponsorAchieve Life SciencesEnrollment810Smoking Cessation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Nancy Rigotti, MD
Mass General/Harvard Medical School
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Alliance for Multispecialty Research, Llc.
Mobile, Alabama, United States
Arizona State University
Phoenix, Arizona, United States
Alliance for Multispecialty Research, Llc
Coral Gables, Florida, United States
Clinical Research Atlanta
Atlanta, Georgia, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, United States
Alliance for Multispecialty Research, Llc
Wichita, Kansas, United States
Amr Lexington
Lexington, Kentucky, United States
Alliance for Multispecialty Research, Llc
New Orleans, Louisiana, United States
Massachusetts General Hospital - Clinical Genetic Research Facility
Boston, Massachusetts, United States
Alliance for Multispecialty Research, Llc
Kansas City, Missouri, United States
Alliance for Multispecialty Research, Llc
Las Vegas, Nevada, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
Alliance for Multispecialty Research, Llc.
Knoxville, Tennessee, United States
Futuresearch Trials of Dallas, Lp
Dallas, Texas, United States
Alliance for Multispecialty Research, Llc
Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CytisinePlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 13 Oct 2020
Primary completion: 23 Dec 2021
Completion: 23 Dec 2021
Last update posted: 15 Jan 2026
Registered enrollment: 810
Registry id: NCT04576949

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.