A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
NCT ID: NCT05206370
Last Updated: 2026-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
792 participants
INTERVENTIONAL
2022-01-20
2023-03-21
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
QUADRUPLE
Study Groups
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Placebo + Behavioral Support
One placebo tablet orally (PO) three times daily (TID) for 12 weeks plus behavioral support
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.
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
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.
12-Week Cytisinicline + Behavioral Support
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
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 all 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 ECG determined after minimum of 5 minutes in supine position within 28 days of randomization (ie, requiring treatment or further assessment).
7. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, or hospitalization for congestive heart failure.
8. Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
9. Currently psychotic or having had a psychotic event within 3 months. If any subject becomes psychotic during the study, they must be removed from treatment and/or additional study visits.
10. Currently having suicidal ideation or risk for suicide ("Yes" to either question 4 or question 5 OR "Yes" to any suicidal behavior question on the Columbia Suicide Severity Rating Scale \[C-SSRS\] with clear suicidal intent or previous attempt).
11. Current symptoms of moderate to severe depression (depression score ≥11on the HADS).
12. Renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min (estimated with the Cockroft-Gault equation).
13. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN).
14. Women who are pregnant or breast-feeding.
15. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
16. Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
17. 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.
18. 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.
19. 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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Daniel Cain, Vice-President Clinical Research
Role: STUDY_DIRECTOR
Achieve Life Sciences, Inc.
Locations
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Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Affinity Health Corp
Oak Brook, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Health Research of Hampton Toads, Inc
Newport News, 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 JJ, Rubinstein M, Clarke A, Blumenstein B, Cain DF, Jacobs C. Cytisinicline for Smoking Cessation: The ORCA Phase 3 Replication Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):648-655. doi: 10.1001/jamainternmed.2025.0628.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ACH-CYT-04
Identifier Type: -
Identifier Source: org_study_id
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