NCT01030406

Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Acura Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

Detailed description

In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.

Conditions

• Opioid Abuse

Interventions

Type	Name	Description
DRUG	40/0mg taken first	8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
DRUG	80/0mg taken first	8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
DRUG	40/240mg taken first	8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
DRUG	80/480mg taken first	8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
DRUG	0/0mg taken first	Placebo All arms taken with a 48 hour washout between doses

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-12-11
• Last updated: 2018-11-01
• Results posted: 2018-11-01

Locations

1 site across 1 country: United States