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Completed

NCT Number: NCT01243060

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

About this study

Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almorexant

Drug

100mg

Zolpidem 10mg

Drug

10mg

Other names: Ambien

Placebo

Drug

One-time dose of Placebo

Primary outcomes

  1. A comparison between dosing groups on performance on neurocognitive measures

    Time frame: Within a 7-hour window post dose.

Sponsors and collaborators

Lead sponsor

Northern California Institute of Research and Education

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2010
Registry last updated
Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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