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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Pain

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Sedation

Principal Investigator

Stuart A Grossman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J0502

NCT ID:

NCT00267332

Start Date:

January 2006

Completion Date:

December 2006

Related Keywords:

  • Cancer
  • Pain
  • Sedation
  • Pain
  • modafinil
  • opioids

Name

Location

The Johns Hopkins HospitalBaltimore, Maryland  21205