Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01987739
Status:
COMPLETED
Last Update Posted:
2016-02-12
First Post:
2013-11-13
Brief Title:
Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users
Sponsor:
Midnight Pharma LLC
Organization:
Midnight Pharma LLC
Study Overview
Official Title:
A Single Center Randomized Double-blind Double-dummy Placebo- and Active-controlled Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System CNS Depressant Drug Users
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a six-way crossover study with six single-dose treatment sessions The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem
Detailed Description:
This was a prospective randomized double-blind double-dummy balanced placebo and active-controlled six-way crossover Phase 1 study with six single-dose treatment sessions The profile of acute effects on pharmacodynamic abuse potential measures of different almorexant doses was compared with that of placebo and two doses of zolpidem
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?:
None