- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00829777
Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects (AIKO-150)
September 14, 2009 updated by: California Pacific Medical Center Research Institute
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
Intervention / Treatment
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.073-2
- PR#0830A
- IRB# 26.073-2
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.
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