NCT02641028已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior
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
- 71
- 试验地点
- 3
- 主要终点
- Latency
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior.
详细描述
The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.
The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.
Each period of the crossover consists of a 7-day out-patient treatment period followed by a single in-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Smoking Lapse Test and be discharged from the clinic to undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent and agrees to complete required clinic visits
- •Male or female 21 to 60 years of age inclusive
- •Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
- •Heavy Smokers
- •Currently not seeking smoking cessation therapy
- •In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 12-lead ECG, vital signs, and clinical laboratory testing)
- •Able to read, write, and speak in English
- •Females must be either:
- •Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
- •Women of childbearing potential (WOCBP) must meet the criteria below:
- •Uses an acceptable double-barrier method of contraception as determined by the Investigator -and-
- •Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.
- •Male subjects must agree to use a condom if partner is of childbearing potential
排除标准
- •Subjects meeting the following criteria are not eligible for the study:
- •Any substance use disorder other than nicotine or caffeine as assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) substance use disorder checklist in addition to the Mini-International Neuropsychiatric Interview (MINI) (to capture both DSM-V substance use disorder diagnoses)
- •Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
- •Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI
- •Current psychiatric conditions that interfere with study conduct, assessment or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc., without permission of the medical monitor
- •Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
- •Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
- •Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor
- •Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN)
- •Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
- •History of severe allergies or multiple adverse drug reactions
- •Known hypersensitivity to CERC-501
- •Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor
- •Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
研究组 & 干预措施
CERC-501
Experimental
Administered orally once daily, 15mg daily, 8 days.
干预措施: CERC-501 (Drug)
Placebo
Placebo Comparator
Administered orally daily, 8 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Latency
时间窗: 50 min
Latency (in minutes and seconds) to time of first cigarette smoked during the delay period
Number of Cigarettes smoked
时间窗: 60 min
Number of cigarettes smoked during the self administration period
次要结局
- Tobacco Craving(Up to 4 days ( 2 each period))
- Mood Scores(Up to 4 days ( 2 each period))
- Nicotine Withdrawal(Up to 4 days ( 2 each period))
- Anxiety Scores(Up to 4 days ( 2 each period))
- Subject Feeling(Up to 4 days ( 2 each period))
- Electronic Diary(up to 51 days)
研究者
研究点 (3)
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