A Study of Cytisinicline for Smoking Cessation in Adult Smokers

Completed · Phase 3 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT04576949

Run by

Achieve Life Sciences

People needed

810

Starts

2020-10-13

Expected to finish

2021-12-23

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, age ≥18 years.
• 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.
• Expired air carbon monoxide (CO) ≥10 ppm.
• Failed at least one previous attempt to stop smoking with or without therapeutic support.
• Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment.
• Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
• Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
• Sign the Informed Consent Form.

You may not qualify if…

• More than 1 study participant in same household.
• Previous cytisinicline treatment in a prior clinical study or any other cytisine usage.
• Known hypersensitivity to cytisinicline or any of the excipients.
• Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline.
• Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring).
• 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).
• Body mass index (BMI) classification for being underweight (<18.5 kg/m\^2) or having ≥Class 2 obesity (≥35 kg/m\^2).
• Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
• Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
• Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic.
• Currently having suicidal ideation or risk for suicide ("Yes" to question 4 or question 5 OR "Yes" to any suicidal behavior question on the Columbia - Suicide Severity Rating Scale [C-SSRS]).
• Current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale[HADS] score ≥11).
• Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min (estimated with the Cockroft-Gault equation).
• Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN).
• Women who are pregnant or breast-feeding.
• Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
• Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
• Treatment with other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to randomization or planned use of these other smoking cessation medications during the study.
• Use within the 2 weeks prior to randomization or planned use during the study of non-cigarette and/or noncombustible nicotine products (pipe tobacco, cigars, snuff, smokeless tobacco, hookah, e-cigarettes/vaping) or marijuana smoking or vaping.
• Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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