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

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.

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.

Inclusion Criteria:

• Subject is male or female between 18 and 55 years old.
• Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2.
• Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is NOT physically dependent on opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will provide written informed consent.
• Subject has a minimum of a 6th grade reading level as determined by the Investigator or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

Exclusion Criteria:

• History or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of DSM-IV-TR.
• History or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.
• Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any component of Acurox Tablets.