Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Almorexant 100mg

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

Group Type EXPERIMENTAL

Almorexant

Intervention Type DRUG

100mg

Almorexant 200mg

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

Group Type EXPERIMENTAL

Almorexant

Intervention Type DRUG

200mg

Zolpidem

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

Group Type ACTIVE_COMPARATOR

Zolpidem 10mg

Intervention Type DRUG

10mg

Placebo

Subjects will receive a one-time dose of Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One-time dose of Placebo

Interventions

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Almorexant

100mg

Intervention Type DRUG

Almorexant

200mg

Intervention Type DRUG

Zolpidem 10mg

10mg

Intervention Type DRUG

Placebo

One-time dose of Placebo

Intervention Type DRUG

Other Intervention Names

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Ambien

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes