A Phase 1 interventional study of 6β-Naltrexol escalating doses from 0.05-0.5 mg IV in Opiate Addiction, sponsored by California Pacific Medical Center Research Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-09-16.
Sponsored by California Pacific Medical Center Research Institute · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 8 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →California Pacific Medical Center Research Institute is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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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.
Also known as: Naloxone, 6β-Naltrexol, Lactulose
- 6β-Naltrexol will have 13 hr half-life. Plasma collected
Time frame: -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
-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
6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests
Time frame: 0-8 hrs post dose
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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California Pacific Medical Center Research Institute