NCT07392125尚未招募3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Primary Efficacy Objective
研究概览
简要总结
This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only.
A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms:
- Arm B, 12 weeks cytisinicline + behavior support: N=400 or
- Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).
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 a point-of-care Oral Fluid Screening Device (OFD) with positive detection at ≥30 ng/mL cotinine.
- •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.
- •Failed at least one previous attempt to stop vaping with or without therapeutic support.
- •Willing to initiate study treatment on the day after randomization and set a quit date within Day 7 and Day
- •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 3 months prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products such as heat not burn products or nicotine pouches (ie, dual users).
- •Currently smoking/vaping cannabis or having smoked or vaped cannabis within 4 weeks (28 days) prior to study randomization or planned use while on study. Other methods of cannabis consumption, eg, edibles, tinctures, capsules, topicals, etc. are allowed.
- •Expired Carbon Monoxide (CO) levels ≥6 ppm, indicating recent combustible tobacco or cannabis smoking.
- •A score of 0-3 on the Penn State e-Cigarette Dependence Index indicating no dependence.
- •More than 1 study subject in same household during the study treatment period.
- •Known hypersensitivity to any of the excipients, previous cytisinicline treatment in a prior clinical study, or any previous use of cytisinicline.
- •Positive urinary drugs of abuse screen determined within 28 days before the first dose of study drug. (Note: Although THC is part of the standard drug screen, it is not necessarily exclusionary. Refer to exclusion criteria #2).
- •Clinically significant abnormal serum chemistry or hematology values, as determined by the investigator, within 28 days of randomization.
- •Clinically significant abnormalities on screening visit 12-lead ECG, as determined by the investigator, after minimum of 5 minutes in supine position within 28 days of randomization.
- •Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
- •Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
- •Currently psychotic or having had a psychotic event in the 3 months prior to the screening visit. 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 3, 4 or 5 OR YES to any suicidal behavior question on the C-SSRS with clear suicidal intent or suicide attempt within the last 10 years).
- •Current symptoms of moderate to severe depression (depression score ≥11 using depression questions on the Hospital Anxiety and Depression Scale [HADS] at screening visit).
- •Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min at screening visit (estimated with the Cockroft-Gault equation and reported by the central laboratory).
- •Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN) at screening visit.
- •Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (eg, pneumonia, product-use associated lung injury or EVALI, etc).
- •Women who are pregnant or breast-feeding.
- •Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
- •True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- •Barrier methods:
- •diaphragm
- •cervical cap
- •contraceptive sponge
- •intrauterine device (IUD)
- •double barrier method (condom with spermicide)
- •Hormonal methods:
- •Oral contraceptives
- •Vaginal ring such as NuvaRing
- •Skin patch such as Xulane
- •Injection such as Depro-Provera
- •Implantable rod such as Nexplanon
- •Intrauterine device (IUD)
- •Participation in a clinical study with an investigational drug or biologic in the 4 weeks prior to study randomization.
- •Use of any smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to study randomization 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 (eg, 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
Arm A
Placebo Comparator
12 weeks of placebo + behavioral support; 400 subjects
干预措施: Placebo (Drug)
Arm A
Placebo Comparator
12 weeks of placebo + behavioral support; 400 subjects
干预措施: Behavioral Support (Behavioral)
Arm B
Active Comparator
12 weeks cytisinicline + behavioral support; 400 subjects
干预措施: Cytisinicline (Drug)
Arm B
Active Comparator
12 weeks cytisinicline + behavioral support; 400 subjects
干预措施: Behavioral Support (Behavioral)
结局指标
主要结局
Primary Efficacy Objective
时间窗: Randomization to Week 24 follow-up visit
Assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 post-randomization as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support). Successful vaping cessation is defined as weekly vaping abstinence during the last 4 weeks of the 12-week treatment period (Week 9 through Week 12) using quantitative cotinine levels at \<10 ng/mL for biochemical verification and subject's self-report of no vaping using a daily electronic diary
次要结局
未报告次要终点
研究者
相似试验
招募中
3 期
A Phase III Study of CM326 in Subjects With Moderate to Severe AsthmaNCT07372287CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.230
尚未招募
3 期
A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）NCT07274137MindRank AI Ltd738
招募中
2 期
A Study of Picankibart in Patients With Active Psoriatic ArthritisPsoriatic ArthritisNCT07295509Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.222
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyNCT07266805Pharvaris Netherlands B.V.32
终止
2 期
A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular PsoriasisGeneralized Pustular PsoriasisNCT07314060Chia Tai Tianqing Pharmaceutical Group Co., Ltd.36