Modafinil in Opioid Induced Sedation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 class of agents used to counteract sedation. Modafinil is a novel stimulant that is FDA approved for the treatment of narcolepsy and has a very different side effect profile than traditional stimulants. The potential role of this agent in the treatment of opioid induced sedation remains undefined. This study, which utilizes a prospective, randomized, blinded, cross-over design, will collect daily information on sedation (Epworth Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the Johns Hopkins Medical Institutions.

Official Title
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A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation

Conditions
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Cancer, Pain

Intervention / Treatment
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* Drug: Modafinil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Modafinil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation |  |  | 
| Pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Pain, modafinil, opioids