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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid Abuse

Intervention / Treatment
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* Drug: 40/0mg taken first
* Drug: 80/0mg taken first
* Drug: 40/240mg taken first
* Drug: 80/480mg taken first
* Drug: 0/0mg taken first


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40/0mg taken first<br>8x oxycodone/niacin 5/0mg tablets | Drug: 40/0mg taken first<br>* 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses<br>|
| Active Comparator: 80/0mg taken first<br>8x oxycodone/niacin 10/0mg tablets | Drug: 80/0mg taken first<br>* 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses<br>|
| Experimental: 40/240mg taken first<br>8x oxycodone/niacin 5/30mg tablets | Drug: 40/240mg taken first<br>* 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses<br>|
| Experimental: 80/480mg taken first<br>8x oxycodone/niacin 10/60mg tablets | Drug: 80/480mg taken first<br>* 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses<br>|
| Placebo Comparator: 0/0mg taken first<br>Placebo | Drug: 0/0mg taken first<br>* Placebo All arms taken with a 48 hour washout between doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Liking at .5 Hours | Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question Do you dislike or like the drug effect you are feeling now? and anchored in the center with Neither like nor dislike (score of 50), on the left with Dislike an awful lot (score of 0) and on the right with Like an awful lot (score of 100). | Measure collected at 0.5 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abuse Liability, Abuse Prevention, Abuse Resistance, Abuse Deterrence