ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
Summary
This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults
to assess the presence, duration, and degree of opiate blockade as well as the safety and
tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio
to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or
300 mg.