Modafinil in Opioid Induced Sedation

Phase 3

Terminated

• Conditions: Pain; Cancer

• Registration Number: NCT00267332
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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 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.

Study Timeline

• Study First Submitted: 2005-12-16
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Study Start: 2006-01
• Study Completion: 2006-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sedation
Pain

Trial Locations

Locations (1)

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States