Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects
NCT ID: NCT00829777
Last Updated: 2009-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2009-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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6β-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 6β-Naltrexol 0.05 mg, 0.15 mg, 0.5 mg with a randomized placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fluent English speaker
* Willing and able to give written consent
Exclusion Criteria
FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
21 Years
45 Years
ALL
No
Sponsors
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California Pacific Medical Center Research Institute
OTHER
Responsible Party
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Addiction & Pharmacology Research Laboratory, California Pacific Medical Center Research Institute
Principal Investigators
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John E Mendelson, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center Research Institute
Locations
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CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, United States
Countries
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Other Identifiers
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PR#0830A
Identifier Type: -
Identifier Source: secondary_id
IRB# 26.073-2
Identifier Type: -
Identifier Source: secondary_id
28.073-2
Identifier Type: -
Identifier Source: org_study_id
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