Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

NCT01243060 | Completed DMC

• 1 other identifier: NEY-1413
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Sleep Aid

Outcome Measures

Primary Outcomes (1)

• A comparison between dosing groups on performance on neurocognitive measures

  Within a 7-hour window post dose.

Study Arms (4)

Almorexant 100mg

EXPERIMENTAL

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

Drug: Almorexant

Almorexant 200mg

EXPERIMENTAL

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

Drug: Almorexant

Zolpidem

ACTIVE COMPARATOR

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

Drug: Zolpidem 10mg

Placebo

PLACEBO COMPARATOR

Subjects will receive a one-time dose of Placebo.

Drug: Placebo

Interventions

Almorexant DRUG

100mg

Almorexant 100mg

Zolpidem 10mg DRUG

10mg

Also known as: Ambien

Zolpidem

Placebo DRUG

One-time dose of Placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Interventions

almorexant; Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Thomas Neylan, M.D.

  Northern California Institute of Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: May 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

US (1)