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

Opiate Addiction Clinical Trial

— AIKO-150  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829777
• Other study ID #: 28.073-2
• Secondary ID: PR#0830AIRB# 26.
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2009
• Last updated: September 14, 2009
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Addiction

Intervention

Drug:
• 6ß-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 6ß-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.

Locations

Country	Name	City	State
United States	CPMC Addiction & Pharmacology Research Laboratory (APRL)	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 6ß-Naltrexol will have 13 hr half-life. Plasma collected		-0-24 hrs post dose	No
Primary	- 6ß-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected		0-8 hrs post dose	Yes
Secondary	-6ß-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	No
Secondary	6ß-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests		0-8 hrs post dose	No