Modafinil in Opioid Induced Sedation

NCT00267332 | Terminated Phase 3

• 1 other identifier: J0502
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain

Keywords

Sedation; Pain; modafinil; opioids

Outcome Measures

Primary Outcomes (2)

• Sedation

• Pain

Interventions

Modafinil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stuart A Grossman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 20, 2005
• Study Start: January 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)