Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects

Phase 1

Completed

• Conditions: Opiate Addiction

• Registration Number: NCT00829777
• Lead Sponsor: California Pacific Medical Center Research Institute

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Study Start: 2009-03
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Opiate dependent males and females age 21-45 on stable doses of methadone
• Fluent English speaker
• Willing and able to give written consent

Exclusion Criteria

• Pregnancy or lactation

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
- 6β-Naltrexol will have 13 hr half-life. Plasma collected	-0-24 hrs post dose
- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected	0-8 hrs post dose

Secondary Outcome Measures

Name	Time	Method
-6β-Naltrexol will have a lower potency in precipitating withdrawal and be better tolerated than Naloxone assessed by vital signs, objective/subjective ate Withdrawal Scales, Visual Analog Scales, Pupil Size and GI Motility measures	0-8 hrs post dose
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests	0-8 hrs post dose

Trial Locations

Locations (1)

CPMC Addiction & Pharmacology Research Laboratory (APRL); 🇺🇸 San Francisco, California, United States