Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
NCT ID: NCT06435221
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
479 participants
INTERVENTIONAL
2024-05-28
2025-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cytisinicline 3 mg TID
Cytisinicline 3 mg TID for 52 weeks.
Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Interventions
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Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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:
* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
* Barrier methods:
* diaphragm
* cervical cap
* contraceptive sponge
* Hormonal methods:
* Oral contraceptives
* Vaginal ring such as NuvaRing
* Skin patch such as Xulane
* Injection such as Depro-Provera
* Implantable rod such as Nexplanon
11. Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment.
12. 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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Julie Ball
Role: STUDY_DIRECTOR
Achieve Life Sciences, Inc.
Locations
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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
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Massachusetts General Hospital - Clinical Genetic Facility
Boston, Massachusetts, United States
Insight Research Institute
Flint, Michigan, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ACH-CYT-13
Identifier Type: -
Identifier Source: org_study_id
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