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

Opioid Abuse Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01030406
Study type Interventional
Source Acura Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date January 2010
Completion date February 2010
View Details
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