ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

Phase 2 Completed 27 enrolled Alkermes, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2002-03
Primary completion: 2003-05
Completion: 2003-05

Publications

Results Bigelow GE, Preston KL, Schmittner J, Dong Q, Gastfriend DR. Opioid challenge evaluation of blockade by extended-release naltrexone in opioid-abusing adults: dose-effects and time-course. Drug Alcohol Depend. 2012 Jun 1;123(1-3):57-65. doi: 10.1016/j.drugalcdep.2011.10.018. Epub 2011 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	75 mg	Intramuscular
Subject	Naltrexone	Small molecule	150 mg	Intramuscular
Subject	Naltrexone	Small molecule	300 mg	Intramuscular
Background	Hydromorphone	Other / unclassified	3 mg	Intramuscular
Background	Hydromorphone	Other / unclassified	4.5 mg	Intramuscular
Background	Hydromorphone	Other / unclassified	6 mg	Intramuscular
Background	Naloxone	Small molecule	—	—

ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

Summary

Timeline

Publications

Drugs

Indications