NCT00699010

Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse

A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Acura Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Abuse

Interventions

Type	Name	Description
DRUG	Acurox 5/30mg taken first	followed by oxycodone 5mg with 48 hour washout
DRUG	Oxycodone 5mg taken first	followed by Acurox 5/30mg with 48 hour washout

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-06-17
• Last updated: 2018-10-03
• Results posted: 2018-10-03

Locations

1 site across 1 country: United States