Modafinil in Opioid Induced Sedation

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• The primary objective of this study is to evaluate the efficacy of modafinil in the treatment of opioid induced sedation as measured by the Epworth Sleepiness Scale (ESS).

• The secondary objective is to estimate the frequency and severity of toxicity associated with Modafinil (400mg) in patients with opioid induced sedation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Analgesics, Opioid; Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• Epworth Sleepiness Scale > 10

• Etiology of sleepiness is attributed only to opioids

• Patient must have been taking an opioid for more than 2 weeks or have been on a non-escalating dose of opioids for at least 1 week

• Patient must be able to give written informed consent

• Age >18 years

Exclusion Criteria:

• Hypersensitivity to modafinil

• Mini-Mental Status Exam (MMSE) < 25/30

• Renal impairment (calculated creatinine clearance < 40)

• Hepatic dysfunction (total bilirubin > 1.8, AST > 75IU/l, ALT > 100IU/l, prothrombin time > 40%

• Known history of cardiovascular disease (i.e., left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, mitral valve prolapse, recent myocardial infarction, unstable angina, uncontrolled hypertension)

• Woman who are pregnant, breast-feeding or on hormonal contraception

• Patients taking tricyclic antidepressants, CNS stimulants, hormonal contraceptives or drugs that are inhibitors or inducers of CYP 3A4