Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267332
Status:
TERMINATED
Last Update Posted:
2018-05-07
First Post:
2005-12-16
Brief Title:
Modafinil in Opioid Induced Sedation
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Randomized Double-Blinded Placebo Controlled Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The secondary objective is to estimate the frequency and severity of toxicity associated with Modafinil 400mg in patients with opioid induced sedation
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None