Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
Phase 1
Completed
- Conditions
- Opiate Addiction
- Registration Number
- NCT00829777
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
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Exclusion Criteria
- Pregnancy or lactation
FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method - 6β-Naltrexol will have 13 hr half-life. Plasma collected -0-24 hrs post dose - 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected 0-8 hrs post dose
- Secondary Outcome Measures
Name Time Method -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 0-8 hrs post dose 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests 0-8 hrs post dose
Trial Locations
- Locations (1)
CPMC Addiction & Pharmacology Research Laboratory (APRL)
🇺🇸San Francisco, California, United States