Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
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.
|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|
- We will measure GABA receptor binding by PET imageing after each dose of study medication or placebo. [ Time Frame: PET scans will occur within 1-2 hours after study drug or placebo administration. Visits will occur approximately 1 week apart. . Subjects will have visits scheduled over approximately 6 weeks, including screening, scanning visits, and follow-up. ] [ Designated as safety issue: No ]
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781482
|United States, Ohio|
|Kettering Medical Center|
|Kettering, Ohio, United States, 45429|
|Principal Investigator:||Joseph C Mantil, MD, PhD||Kettering Health Network|