NCT05431387已完成2 期
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adults Using Nicotine-containing E-cigarettes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Percentage of Participants With Vaping Abstinence From Week 9 to 12
研究概览
简要总结
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.
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.
- •Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at ≥ 30 ng/mL cotinine level).
- •Current daily nicotine-containing electronic cigarette usage as recorded in a screening diary for at least 7 consecutive days. Willing to bring the e-cigarette or nicotine device used to the clinical site so that the specific product type, flavor, and nicotine level can be documented.
- •Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment.
- •Willing to actively participate in the study's vaping 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.
排除标准
- •Currently smoking, or having smoked within 4 weeks prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products (such as heat not burn products) (i.e., dual users).
- •Expired carbon monoxide (CO) levels ≥ 10 ppm, indicating recent combustible tobacco use.
- •More than 1 study participant in same household during the study treatment period.
- •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 (Note: tetrahydrocannabinol (THC) is not part of the abuse screen).
- •Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring).
- •Clinically significant abnormalities in 12-lead electrocardiogram determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e., 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).
- •Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic; having suicidal ideation within the last 3 months (corresponding to question 4 or 5 on the Columbia - Suicide Severity Rating Scale [C-SSRS]); or current symptoms of moderate to severe depression (depression score ≥ 11 on the HADS) within the last 3 months.
- •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).
- •Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (e.g., pneumonia, product-use associated lung injury or e-cigarette or vaping use-associated lung injury [EVALI], etc.)
- •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 starting at the time of consent, during the study treatment period, and continuing for one month after ending study treatment.
- •Participation in a clinical study with an investigational drug in the 4 weeks prior to study randomization.
- •Use of other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to study randomization, any previous cytisinicline use, or planned use of these or other nicotine replacement medications during the study.
- •Any planned use during the study of combustible cigarettes or other nicotine-containing, non-vaping products (e.g., pipe tobacco, cigars, snuff, smokeless tobacco, hookah, ZYN pouches, etc).
- •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
Placebo Comparator
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
干预措施: Placebo (Drug)
Placebo + Behavioral Support
Placebo Comparator
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
干预措施: Behavioral support (Behavioral)
Cytisinicline + Behavioral Support
Experimental
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
干预措施: cytisinicline (Drug)
Cytisinicline + Behavioral Support
Experimental
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
干预措施: Behavioral support (Behavioral)
结局指标
主要结局
Percentage of Participants With Vaping Abstinence From Week 9 to 12
时间窗: Weeks 9 to 12
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
次要结局
- Percentage of Participants With Vaping Abstinence From Week 3 to 6(Weeks 3 to 6)
- Percentage of Participants With Vaping Abstinence From Week 6 to 9(Weeks 6 to 9)
- Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates)(Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12(Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Percentage of Participants With Vaping Abstinence From Week 9 to 16(Weeks 9 to 16)
研究者
研究点 (5)
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