Purpose

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female subjects, age ≥18 years. 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

  1. More than 1 study participant in same household. 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. BMI classification for being underweight (<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2). 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 C-SSRS). 12. Current symptoms of moderate to severe depression (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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
  • Drug: Placebo
    film-coated oral tablets containing matched placebo
  • Behavioral: 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.
Experimental
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
  • Drug: Cytisinicline
    film-coated oral tablets containing 3 mg cytisinicline
    Other names:
    • Cytisine
  • Drug: Placebo
    film-coated oral tablets containing matched placebo
  • Behavioral: 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.
Experimental
Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
  • Drug: Cytisinicline
    film-coated oral tablets containing 3 mg cytisinicline
    Other names:
    • Cytisine
  • Behavioral: 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.

Recruiting Locations

Massachusetts General Hospital - Clinical Genetic Research Facility
Boston, Massachusetts 02114
Contact:
Nancy A Rigotti, MD

More Details

Status
Recruiting
Sponsor
Achieve Life Sciences

Study Contact

Daniel Cain, Vice-President Clinical Research
425.686.1546
dcain@achievelifesciences.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.