Effect of Extended-release Oxymorphone Taking With or Without Food on Cognitive Functioning
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older 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