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

California Pacific Medical Center Research Institute

Status and phase: Completed; Phase 1

Conditions: Opiate Addiction

Treatments: Drug: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT00829777

IRB# 26.073-2

28.073-2

PR#0830A

Details and patient eligibility

About

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

Enrollment: 8 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind