Modafinil in Opioid Induced Sedation

Condition(s) targeted: Cancer; Pain

Intervention: Modafinil (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Stuart A Grossman, MD, Principal Investigator, Affiliation: Johns Hopkins University

- 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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Sedation

Pain

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 (Epsworth Sleepiness Scale), pain, opioid consumption, and adverse effects in 90 patients suffering from opioid induced sedation within the Johns Hopkins Medical Institutions.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- MMES < 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 (see Appendix D)

The Johns Hopkins Hospital, Baltimore, Maryland 21205, United States

Starting date: January 2006
Ending date: December 2006
Last updated: April 23, 2007