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Healthy Volunteers | Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Healthy Volunteers research study

What is the primary objective of this study?

In recent years, there has been increased focus on cognitive side effects of sleep-inducing medications that may contribute to unusual behavior during unexpected awakenings during the night. Concerns regarding these side effects have led to a class Food and Drug Administration (FDA) warning for all sleep-inducing medications. Almorexant is an experimental sleep-inducing medication in a new class of medications that is being extensively developed by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in the brain that function with proteins called hypocretins. The goal of this study is to evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep aid) or placebo.

Who is eligible to participate?

To participate in the study, participants must: - Be between the ages of 19 and 39 - Be in good physical health - Be a good sleeper with consistent bedtimes and wake times - Not have problems falling or staying asleep - Be a non-smoker - Meet our other study criteria

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy Volunteers

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Almorexant100mg

Drug:Almorexant200mg

Drug:Zolpidem 10mg10mg

Drug:PlaceboOne-time dose of Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Almorexant 100mgSubjects will receive a one-time dose of Almorexant 100mg.

Almorexant 200mgSubjects will receive a one-time dose of Almorexant 200mg.

ZolpidemSubjects will receive a one-time dose of Zolpidem 10mg.

PlaceboSubjects will receive a one-time dose of Placebo.

Study Status

Completed

Start Date: May 2011

Completed Date: July 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: A comparison between dosing groups on performance on neurocognitive measures

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Thomas Neylan, M.D.

Lead Sponsor: Northern California Institute of Research and Education

Collaborator: U.S. Army Medical Research and Materiel Command

More information:https://clinicaltrials.gov/show/NCT01243060

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