A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted

Phase 1 Completed 45 enrolled Pfizer Syneos Health · collab

RandomizedCrossoverDouble-blindOther

Summary

The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.

Timeline

Start: 2013-02
Primary completion: 2013-07
Completion: 2013-07

Publications

Setnik B, Bramson C, Bass A, Levy-Cooperman N, Malhotra B, Matschke K, Sommerville KW, Wolfram G, Geoffroy P. Intranasal administration of crushed ALO-02 (extended-release oxycodone with sequestered naltrexone): A randomized, controlled abuse-potential study in nondependent recreational opioid users. J Clin Pharmacol. 2015 Dec;55(12):1351-61. doi: 10.1002/jcph.552. Epub 2015 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALO-02	Unknown	3.6 mg	Intranasal
Subject	ALO-02	Unknown	30 mg	Intranasal
Comparator	Oxycodone	Other / unclassified	30 mg	Intranasal

Indications

No indication recorded.