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临床试验/NCT04273776
NCT04273776进行中(未招募)早期 1 期

A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study

Walter Reed Army Institute of Research (WRAIR)1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Suvorexant Arm

Active Comparator

10 mg of Suvorexant

干预措施: Suvorexant 10 mg (Drug)

Suvorexant Arm

Active Comparator

10 mg of Suvorexant

干预措施: Placebos (Drug)

Zolpidem Arm

Active Comparator

5 mg of Zolpidem

干预措施: Zolpidem (Drug)

Zolpidem Arm

Active Comparator

5 mg of Zolpidem

干预措施: Placebos (Drug)

Placebo

Placebo Comparator

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

研究者

发起方
Walter Reed Army Institute of Research (WRAIR)
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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