NCT03879460

The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Timothy Smith · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Intoxication

Interventions

Type	Name	Description
DRUG	Naltrexone Hydrochloride	50 mg per os naltrexone hydrochloride

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2019-03-18
• Last updated: 2019-05-17

Locations

1 site across 1 country: Canada