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

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.

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94110
        • CPMC Addiction & Pharmacology Research Laboratory (APRL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
-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
Time Frame: 0-8 hrs post dose
0-8 hrs post dose
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests
Time Frame: 0-8 hrs post dose
0-8 hrs post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John E Mendelson, MD, California Pacific Medical Center Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opiate Addiction

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