Modafinil in Opioid Induced Sedation

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00267332
First received: December 16, 2005
Last updated: April 23, 2007
Last verified: April 2007

December 16, 2005
April 23, 2007
January 2006
Not Provided
  • Sedation
  • Pain
Same as current
Complete list of historical versions of study NCT00267332 on ClinicalTrials.gov Archive Site
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Modafinil in Opioid Induced Sedation
A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
  • 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cancer
  • Pain
Drug: Modafinil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
December 2006
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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

    • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00267332
J0502
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Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Stuart A Grossman, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP