Conditions: Chronic Pain
Keywords: opioid tolerant chronic pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose, whether given on an empty stomach or after a high-fat meal, suggesting that the altered pharmacokinetics, fed versus fasting and as described above, is not relevant for the medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be without merit.

Arms:
arm 1: Participants received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal arm 2: Participants received 40 mg oxymorphone ER after fasting for 8-12 hours

Interventions: intervention 1: Oxymorphone ER
Intervention descriptions: intervention 1: 40 mg qd twice

Protocol document: