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A Study of Cytisinicline for Smoking Cessation in Adult Smokers | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Cytisinicline for Smoking Cessation in Adult Smokers

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

NCT04576949•Achieve Life Sciences

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects, age ≥18 years.
•2. Current daily cigarette smokers (averaging at least 10 cigarettes per day upon completing a 7-day screening smoking diary) and who intend to quit smoking.
•3. Expired air carbon monoxide (CO) ≥10 ppm.
•4. Failed at least one previous attempt to stop smoking with or without therapeutic support.
•5. Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment.
•6. Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
•7. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
•8. Sign the Informed Consent Form.

Exclusion Criteria

•1. More than 1 study participant in same household.
•2. Previous cytisinicline treatment in a prior clinical study or any other cytisine usage.
•3. Known hypersensitivity to cytisinicline or any of the excipients.
•4. Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline.
•5. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring).
•6. Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (ie, requiring treatment or further assessment).
•7. Body mass index (BMI) classification for being underweight (\<18.5 kg/m\^2) or having ≥Class 2 obesity (≥35 kg/m\^2).
•8. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
•9. Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
•10. Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic.
+10 more criteria

Locations (17)

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

Key Dates

Start Date

October 13, 2020

Primary Completion Date

December 23, 2021

Completion Date

December 23, 2021

Last Updated

January 15, 2026

Enrollment

810

ACTUAL participants

Conditions

Smoking Cessation

Interventions

Cytisinicline

DRUG

Placebo

DRUG

Behavioral support

BEHAVIORAL

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

NCT07441928

Smoking CessationSchizophenia Disorder

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RECRUITINGPHASE2

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

NCT05733767

Cardiopulmonary DiseaseSmoking Cessation+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Cytisinicline for Smoking Cessation in Adult Smokers

Inclusion Criteria

Exclusion Criteria

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

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