Status:
COMPLETED
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
Lead Sponsor:
Achieve Life Sciences
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 durati...
Eligibility Criteria
Inclusion
- Male or female subjects, age ≥ 18 years.
- 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.
- Expired air carbon monoxide (CO) ≥ 10 ppm.
- Failed at least one previous attempt to stop smoking with or without therapeutic support.
- Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment.
- Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
- Able to fully understand all study requirements, willing to participate, and comply with dosing schedule.
- Sign the Informed Consent Form.
Exclusion
- More than 1 study participant in same household during the 12-week treatment period.
- Previous cytisinicline treatment in a prior clinical study or any other cytisine usage.
- Known hypersensitivity to cytisinicline or any of the excipients.
- Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline.
- Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring).
- 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).
- Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, or hospitalization for congestive heart failure.
- Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
- 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.
- 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 C-SSRS with clear suicidal intent or previous attempt).
- Current symptoms of moderate to severe depression (depression score ≥11on the HADS).
- Renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min (estimated with the Cockroft-Gault equation).
- Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN).
- Women who are pregnant or breast-feeding.
- Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
- Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
- 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.
- 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.
- Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
792 Patients enrolled
Trial Details
Trial ID
NCT05206370
Start Date
January 20 2022
End Date
March 21 2023
Last Update
March 19 2024
Active Locations (12)
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1
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States, 32720
2
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States, 33912
3
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
4
Affinity Health Corp
Oak Brook, Illinois, United States, 60523