A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

Summary

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

Timeline

Start

2013-02

Primary completion

2013-08-09

Completion

2013-08-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); ALO-02 60 Mg-I vs OXY 60 mg; p <0.0001; LS Mean Difference 49.3 (95% CI 39.2 to 59.5) NCT01746901 ↗

registry analysis (superiority or other test); ALO-02 60 Mg-I vs OXY 60 mg; p <0.0001; LS Mean Difference 63.2 (95% CI 51.5 to 74.9) NCT01746901 ↗

registry analysis (superiority or other test); ALO-02 60 Mg-I vs OXY 60 mg; p <0.0001; LS Mean Difference 108.0 (95% CI 91.6 to 124.5) NCT01746901 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	4.8 mg	Oral
Subject	Naltrexone	Small molecule	7.2 mg	Oral
Comparator	Oxycodone	Other / unclassified	40 mg	Oral
Comparator	Oxycodone	Other / unclassified	60 mg	Oral

Indications

No indication recorded.