A Study of Cytisinicline for Smoking Cessation in Adult Smokers
NCT ID: NCT04576949
Last Updated: 2026-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
810 participants
INTERVENTIONAL
2020-10-13
2021-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
Placebo
film-coated oral tablets containing matched placebo
Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
Cytisinicline + Placebo + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Placebo
film-coated oral tablets containing matched placebo
Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
Interventions
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Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Placebo
film-coated oral tablets containing matched placebo
Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
11. 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 \[C-SSRS\]).
12. Current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale\[HADS\] score ≥11).
13. Renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min (estimated with the Cockroft-Gault equation).
14. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN).
15. Women who are pregnant or breast-feeding.
16. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
17. Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
18. 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.
19. 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.
20. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
18 Years
ALL
No
Sponsors
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Achieve Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Rigotti, MD
Role: PRINCIPAL_INVESTIGATOR
Mass General/Harvard Medical School
Locations
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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
Countries
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References
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Prochaska J, Rubinstein M, Perdok R, Blumenstein B, Jacobs C. Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials. Thorax. 2025 Sep 17:thorax-2025-223880. doi: 10.1136/thorax-2025-223880. Online ahead of print.
Rigotti NA, Benowitz NL, Prochaska J, Leischow S, Nides M, Blumenstein B, Clarke A, Cain D, Jacobs C. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ACH-CYT-03
Identifier Type: -
Identifier Source: org_study_id
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