Modafinil in Opioid Induced Sedation

May 2, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain
Sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Stuart A Grossman, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 16, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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