Modafinil in Opioid Induced Sedation - Full Text View

Sponsor:	Sidney Kimmel Comprehensive Cancer Center
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00267332

Purpose

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	Intervention	Phase
Cancer Pain	Drug: Modafinil	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

Sedation
Pain

Estimated Enrollment:	90
Study Start Date:	January 2006
Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267332

Locations

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

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Investigators

Principal Investigator:

Stuart A Grossman, MD

Johns Hopkins University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00267332 History of Changes
Other Study ID Numbers:	J0502
Study First Received:	December 16, 2005
Last Updated:	April 23, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

Sedation
Pain
modafinil
opioids

Additional relevant MeSH terms:

Modafinil
Analgesics, Opioid
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Neuroprotective Agents
Protective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012