Modafinil in Opioid Induced Sedation

Stopped early · Phase 3

Conditions studied: Cancer, Pain

In brief

* 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.

Key facts

Study ID

NCT00267332

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

90

Starts

2006-01-01

Expected to finish

2006-12-01

Last updated by the study team

2018-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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