Modafinil in Opioid Induced Sedation



Status:Terminated
Conditions:Cancer, Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/9/2018
Start Date:January 2006
End Date:December 2006

Use our guide to learn which trials are right for you!

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 (Epworth 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

- 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
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
1149
mi
from
Baltimore, MD
Click here to add this to my saved trials