|ClinicalTrials.gov Identifier: NCT04576949|
Recruitment Status :
First Posted : October 6, 2020
Last Update Posted : February 21, 2021
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 or disease||Intervention/treatment||Phase|
Behavioral: Behavioral support
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 study requirements, willing to participate, and comply with dosing schedule.
- Sign the Informed Consent Form.
- More than 1 study participant in same household.
- 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).
- BMI classification for being underweight (<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2).
- 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).
- Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic.
- 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).
- Current symptoms of moderate to severe depression (HADS score ≥11).
- 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.