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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Opioid Abuse

Intervention / Treatment
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* Drug: Acurox 5/30mg taken first
* Drug: Oxycodone 5mg 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 of age Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone Body weight is not more than 20% above or below ideal body weight Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the Investigator) or alcohol Subject is in generally good health Subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level Subject has an acceptable score on the MMSE for cognitive impairment For women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control Exclusion Criteria: Subject has a disease that may endanger the subject or the validity of the data Subject is currently physically dependent on opiates or alcohol Subject was exposed to any investigational drug within 30 days prior to the inpatient phase Subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation Subject has a positive urine drug screen for a non-opiate drug Subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient phase Subject has an abnormal bleeding tendency

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: Acurox 5/30mg taken first<br>oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose | Drug: Acurox 5/30mg taken first<br>* followed by oxycodone 5mg with 48 hour washout<br>|
| Active Comparator: Oxycodone 5mg taken first<br>oxycodone HCl 5mg tablets; 8 tablets per dose | Drug: Oxycodone 5mg taken first<br>* followed by Acurox 5/30mg with 48 hour washout<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min) | Do you dislike or like the drug effect you are feeling now? This question was rated on a 1 to 29 point VAS scale that was anchored in the center with neither like nor dislike (14), on the left with dislike an awful lot (1), and on the right with like an awful lot (29). | Effects assessed at 0.5 hours after dosing. | 

 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