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Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem

NCT00781482 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-02-26

No results posted yet for this study

Summary

This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in the brain. We want to show that we can use positron emission tomography images to measure the binding of these medications to the receptors.

Conditions

  • Healthy

Interventions

DRUG

eszopiclone, zolpidem, placebo

In random order, each subject will receive one study drug per visit over three visits. Visits will occur about 1 week apart. Each subject will eventually receive eszopiclone 3 mg., zolpidem 10 mg., and a placebo. PET scans will be done 1-2 hours after each dose.

Sponsors & Collaborators

  • Abiant, Inc.

    collaborator INDUSTRY

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Kettering Health Network

    lead OTHER

Principal Investigators

  • Joseph C Mantil, MD, PhD · Kettering Health Network

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781482 on ClinicalTrials.gov