A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- consolidation of episodic memory
研究概览
简要总结
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Study sessions will be randomized prior to the study (e.g. Session 1 = placebo, Session 2 = zolpidem, etc.) and volunteers will be assigned a session (treatment group) when they are scheduled for their enrollment visit (Day 1). The randomization schedule will be generated using a random number generator by a person who is not involved in data collection prior to commencement of the study, with the following qualification (hence "pseudo-random"): that all volunteers participating in the same session be randomized or "blocked" together (i.e., assigned the same condition). This will help ensure double-blinding since it may be obvious to volunteers and staff within the same session if some volunteers receive placebo whereas others receive active drug. To help maintain confidentiality, each participant will also be given a unique numerical identifier (e.g., 01-120).
入排标准
- 年龄范围
- 18 Years 至 39 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Suvorexant Arm
10 mg of Suvorexant
干预措施: Suvorexant 10 mg (Drug)
Suvorexant Arm
10 mg of Suvorexant
干预措施: Placebos (Drug)
Zolpidem Arm
5 mg of Zolpidem
干预措施: Zolpidem (Drug)
Zolpidem Arm
5 mg of Zolpidem
干预措施: Placebos (Drug)
Placebo
10mg of Avicel
干预措施: Placebos (Drug)
结局指标
主要结局
consolidation of episodic memory
时间窗: 5 days
presentation of word lists
psychomotor vigilance test
时间窗: 4 days
measures reaction time
次要结局
未报告次要终点
