Effect of Extended-release Oxymorphone Taking With or Without Food on Cognitive Functioning
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The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Man or woman, 18-65 years of age, inclusive
Able to provide informed consent and comply with all study procedures
Women of childbearing potential with a negative urine pregnancy test at screening and on adequate contraception
Chronic, non-malignant, painful condition, treated with long-acting opioid (methadone, OxyContin®, MS Contin®, Kadian®, Avinza®, Fentanyl®, Opana® ER)
Opioid treatment for at least 3 months prior to screening at a minimum dose of 90 mg of morphine equivalents per day or 50 mcg of the fentanyl transdermal patch
Dose of opioid treatment stable for at least 1 week prior to screening and expected to be stable from screening through end of second testing
Weight at screening 100-300 pounds, inclusive
Pregnant or breastfeeding
Gastrointestinal disorder or S/P gastrointestinal surgery impacting absorption of study medication (delayed gastric emptying, partial or complete gastrectomy)
Alcohol or substance abuse within 2 years of screening
Consumption of alcohol within 24 hours of a screening or testing visit
Consumption of xanthine-containing beverages (coffee, tea, coke) on the morning of a screening or testing visit
Impaired kidney or liver function (transaminase levels more than 3 times elevated; estimated creatinine clearance less than 50 mL/min)
Epworth sleepiness scale (ESS) score 16 or higher at screening
Medically concerning hypertension (≥ 160/100) or unstable cardiovascular illness
Any clinically significant illness that would interfere with study participation or put the subject at risk
Exposure to investigational medication within 30 days of screening