Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

Study Overview
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Brief Summary
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The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).

Official Title
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An Exploratory, Single-Dose, Double-Blind, Randomized, Placebo-Controlled Crossover Study to Evaluate The Subjective and Objective Effects of Extended-Release Oxymorphone Compared to Controlled-Release Oxycodone in Healthy Non-Dependent Recreational Opioid Users

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxymorphone ER
* Drug: Oxycodone CR
* Drug: Placebo
* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recreational opioid use. At least 3 lifetime occasions of recreational use of an oral intact modified-release opioid product. BMI within range of 19.0 to 29.9 kg/m2, inclusive, minimum weight of 50.0 kg at screening and Day 0 of treatment period 1 Exclusion Criteria: Self-reported history of drug or alcohol dependence in the past 2 years or presence of drug or alcohol dependence in the past 12 months as defined by the DSM-IV, including subjects who have ever been in a drug rehabilitation program. Unwillingness or inability to abstain from recreational drug use as required for the study. History of acute asthma or other obstructive airway disease or any condition that may increase the risk for respiratory depression, judged as clinically significant by the investigator or designee. History of neurologic conditions such as convulsive disorders or severe head injury, judged as clinically significant by the investigator or qualified designee. History of Addison's disease, hypothyroidism, pancreatitis, prostatic hypertrophy, or urethral stricture. Use of non-prescription or prescription medications or natural health products within 7 days prior to first drug administration in the qualification phase and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject. Uses of Monoamine oxidize inhibitors (MAOIs) within 14 days of first drug administration in the qualification phase and throughout the study. Current consumption of greater than 20 cigarettes (or 2 cigars) per day or inability to abstain from smoking (or use of any nicotine-containing sub stance) for at least 14 hours.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymorphone ER 15 mg<br>15mg | Drug: Oxymorphone ER<br>* 15mg or 30mg<br>* Other names: Opana;Drug: Hydromorphone<br>* 8 mg<br>|
| Active Comparator: Oxycodone CR 30 mg<br>30mg | Drug: Oxycodone CR<br>* 30mg or 60mg<br>* Other names: Oxycontin;Drug: Hydromorphone<br>* 8 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The placebo was a sugar pill.<br>Drug: Hydromorphone<br>* 8 mg<br>|
| Experimental: Oxymorphone ER 30mg<br>30mg | Drug: Oxymorphone ER<br>* 15mg or 30mg<br>* Other names: Opana;Drug: Hydromorphone<br>* 8 mg<br>|
| Active Comparator: Oxycodone CR 60mg<br>60mg | Drug: Oxycodone CR<br>* 30mg or 60mg<br>* Other names: Oxycontin;Drug: Hydromorphone<br>* 8 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High VAS - Emax (mm) | The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line. | High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Recreational, Oxymorphone, Oxycodone, Extended Release, Healthy NonDependent Recreational Opioid Users