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| ID | Type | Description | Link |
|---|---|---|---|
| PR#0830A | |||
| IRB# 26.073-2 |
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The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6β-Naltrexol escalating doses from 0.05-0.5 mg IV | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| - 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 |
| Measure | Description | 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 | 0-8 hrs post dose | |
| 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests |
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Inclusion Criteria:
Exclusion Criteria:
FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
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| Name | Affiliation | Role |
|---|---|---|
| John E Mendelson, MD | California Pacific Medical Center Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPMC Addiction & Pharmacology Research Laboratory (APRL) | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 0-8 hrs post dose |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |