Conditions: Opioid Abuse
Keywords: Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.

Detailed description:
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).

All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.

Arms:
arm 1: oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose arm 2: oxycodone HCl 5mg tablets; 8 tablets per dose

Interventions: intervention 1: Acurox 5/30mg taken first intervention 2: Oxycodone 5mg taken first
Intervention descriptions: intervention 1: followed by oxycodone 5mg with 48 hour washout intervention 2: followed by Acurox 5/30mg with 48 hour washout

Protocol document: