NCT00829777

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

A Phase-I, Two-Stage, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Trial of Low Doses of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: California Pacific Medical Center Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Opiate Addiction

Interventions

Type	Name	Description
DRUG	6β-Naltrexol escalating doses from 0.05-0.5 mg IV	Drug: Naloxone 0.1 mg IV/5 minutes to all subjects to determine tolerability to precipitated withdrawal during screening. Those that tolerate withdrawal proceed to Stage 1: Drug: Lactulose 10 gm orally plus 3 IV infusions 30 minutes apart of Naloxone 0.1 mg IV and 2 placebo given randomly to all subjects. If tolerated, proceed to 5 additional medication dosing sessions with all subjects receiving oral Lactulose 10 GM plus IV escalating 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-01-27
• Last updated: 2009-09-16

Locations

1 site across 1 country: United States