Ignite Creation Date:
2025-12-18 @ 9:03 AM
Ignite Modification Date:
2025-12-18 @ 9:03 AM
Study NCT ID:
NCT00781482
Status:
None
Last Update Posted:
2016-02-26 00:00:00
First Post:
2008-10-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
Sponsor:
None
Organization:
Study Overview
Official Title:
Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
Status:
None
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor elected not to conduct study at this time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: