Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT00267332
Eligibility 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00267332
Study Brief:
Protocol Section:
NCT00267332