Clinical trial NCT00955110: Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Opioid
Recreational
Oxymorphone
Oxycodone
Extended Release
Healthy NonDependent Recreational Opioid Users
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Kendle Early Stage - Toronto
First posted: 2009-08-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: High VAS - Emax (mm)
timeFrame: High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
References:
citation: Schoedel KA, McMorn S, Chakraborty B, Zerbe K, Sellers EM. Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. Pain Physician. 2010 Nov-Dec;13(6):561-73.