Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
Information source: California Pacific Medical Center Research Institute
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Addiction
Intervention: 6β-Naltrexol escalating doses from 0.05-0.5 mg IV (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: California Pacific Medical Center Research Institute Official(s) and/or principal investigator(s):
John E Mendelson, MD, Principal Investigator, Affiliation: California Pacific Medical Center Research Institute
Overall contact:
Will Harris, Phone: 415-641-3370, Email: HarrisCW@sutterhealth.org
Summary
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol
administered to opiate dependent subjects
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: - 6β-Naltrexol will have 13 hr half-life. Plasma collected- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected
Secondary outcome: -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 measures6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests
Eligibility
Minimum age: 21 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Will Harris, Phone: 415-641-3370, Email: HarrisCW@sutterhealth.org
CPMC Addiction & Pharmacology Research Laboratory (APRL), San Francisco, California 94110, United States
Additional Information
Starting date: February 2009
Ending date: September 2009
Last updated: January 26, 2009
|
