Status:
TERMINATED
Modafinil in Opioid Induced Sedation
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Sedation is a common side effect of opioid analgesics. In patients where this remains a dose limiting toxicity, stimulants (caffeine, methylphenidate, ephedrine, amphetamine) have been the primary cla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00267332
Start Date
January 1 2006
End Date
December 1 2006
Last Update
May 7 2018
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205