Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Opiate Addiction
Interventions
DRUG

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."

Trial Locations (1)

94110

CPMC Addiction & Pharmacology Research Laboratory (APRL), San Francisco

All Listed Sponsors
lead

California Pacific Medical Center Research Institute

OTHER