A Second Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6
研究概览
简要总结
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 and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 Columbia Suicide Severity Rating Scale [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.
研究组 & 干预措施
Placebo + Behavioral Support
One placebo tablet orally (PO) three times daily (TID) for 12 weeks plus behavioral support
干预措施: Placebo (Drug)
Placebo + Behavioral Support
One placebo tablet orally (PO) three times daily (TID) for 12 weeks plus behavioral support
干预措施: Behavioral support (Behavioral)
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
干预措施: Cytisinicline (Drug)
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
干预措施: Placebo (Drug)
6-Week Cytisinicline + 6-Week Placebo + Behavioral Support
One cytisinicline tablet PO TID for 6 weeks followed by one placebo tablet PO TID for 6 weeks plus behavioral support
干预措施: Behavioral support (Behavioral)
12-Week Cytisinicline + Behavioral Support
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
干预措施: Cytisinicline (Drug)
12-Week Cytisinicline + Behavioral Support
One cytisinicline tablet PO TID for 12 weeks plus behavioral support
干预措施: Behavioral support (Behavioral)
结局指标
主要结局
Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6
时间窗: Weeks 3 to 6
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤ 10 parts per million (ppm).
Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12
时间窗: Weeks 9 to 12
Smoking abstinence as verified by weekly expired CO measurements ≤ 10 ppm.
次要结局
- Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24(Week 3 to Week 24)
- Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24(Week 9 to Week 24)
- Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24(Week 24)