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Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID

NCT06435221•Achieve Life Sciences

Summary

Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies.
•2. Former ORCA-2/ORCA-3 and ORCA-V1 subjects who are current daily cigarette smokers and/or daily nicotine-containing electronic cigarette users. Amount of daily combustible and/or nicotine containing electronic cigarette use at baseline is determined by subject self-report.
•3. At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes.
•4. Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment.
•5. Willing to actively participate in the study's cessation behavioral support provided throughout the study.
•6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
•7. Sign the Informed Consent Form.

Exclusion Criteria

•1. Known hypersensitivity to cytisinicline or any of the excipients.
•2. Clinically significant abnormal screening serum chemistry or hematology values.
•3. Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment).
•4. Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
•5. Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
•6. Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide (corresponding to question 4 or 5 on the screening C-SSRS OR "Yes" to any suicidal behavior question on the screening C-SSRS with clear suicidal intent or previous attempt); or current symptoms of moderate to severe depression (depression score ≥11 on the HADS) at screening. If any subject becomes psychotic during the study, they must be removed from cytisinicline treatment and/or additional study visits.
•7. Severe renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min on screening lab (estimated with the Cockroft-Gault equation).
•8. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN) on screening lab.
•9. Women who are pregnant or breast-feeding.
•10. Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
+13 more criteria

Locations (29)

Alliance for Multispecialty Research, LLC

Mobile, Alabama, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, United States

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, United States

Accel Research Sites Network - 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

Precision Clinical Research

Sunrise, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, United States

Key Dates

Start Date

May 28, 2024

Primary Completion Date

September 29, 2025

Completion Date

October 6, 2025

Last Updated

November 26, 2025

Enrollment

479

ACTUAL participants

Conditions

Smoking CessationVaping Cessation

Interventions

Cytisinicline

DRUG

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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: November 26, 2025Data 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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Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

Inclusion Criteria

Exclusion Criteria

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