The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
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.
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, United States
- 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
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