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| Sponsor: | Kettering Health Network |
|---|---|
| Collaborators: |
Abiant, Inc. Sunovion |
| Information provided by: | Kettering Health Network |
| ClinicalTrials.gov Identifier: | NCT00781482 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: eszopiclone, zolpidem, placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem |
| Estimated Enrollment: | 4 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
This is a crossover study. Each study drug will be administered (one at a time and in random order) to each subject on separate occasions over the course of the study.
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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.
Other Names:
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We will enroll 4 normal, healthy, adult male volunteers who will undergo screening tests (labs, EKGs, medical history, physical exam, and MRI of the brain) for safety. If eligible, they will return for three separate positron emission tomography (PET) scans. Over the course of the three study visits, each subject will receive eszopiclone (Lunesta), zolpidem (ambien) and a placebo in random order.
After each medication or placebo dose, a PET scan will be done using a [11-C] flumazenil (Romazicon). The flumazenil will help us measure the binding of the study medications to chemical receptors called GABA receptors in certain parts of the brain.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Kettering Medical Center | |
| Kettering, Ohio, United States, 45429 | |
| Principal Investigator: | Joseph C Mantil, MD, PhD | Kettering Health Network |
More Information
| Responsible Party: | Joseph Mantil, MD, PhD, Kettering Health Network |
| ClinicalTrials.gov Identifier: | NCT00781482 History of Changes |
| Other Study ID Numbers: | 07-104-SEPR |
| Study First Received: | October 27, 2008 |
| Last Updated: | January 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Positron Emission Tomography GABA receptor binding Hypnotic Drugs Eszopiclone |
Zolpidem [11-C] Flumazenil Molecular imaging of the brain |
|
Zolpidem Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |