Modafinil in Opioid Induced Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267332
Recruitment Status : Terminated (Low accrual)
First Posted : December 20, 2005
Last Update Posted : April 24, 2007
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Modafinil Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
Study Start Date : January 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Sedation
  2. Pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00267332

United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Principal Investigator: Stuart A Grossman, MD Johns Hopkins University Identifier: NCT00267332     History of Changes
Other Study ID Numbers: J0502
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action