Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT03879460
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2019-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
Sponsor:
Timothy Smith
Organization:
Study Overview
Official Title:
The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations
Status:
COMPLETED
Status Verified Date:
2019-05
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:
TEST CANADA
Brief Summary:
The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. The physical and mental/cognitive performance assessments will be conducted at various times prior, during and following drug administration. Daily blood draws will also be taken to assess blood levels of naltrexone and active metabolites for correlation to performance parameters associated with the Military Skill \& Tasked Based Fitness Test.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: