Clinical trial · Interventional
Modafinil in Opioid Induced Sedation
A Randomized Double-Blinded, Placebo Controlled, Crossover Trial Examining the Effectiveness of Modafinil in Opioid Induced Sedation
NCT00267332CI-TRIAL-00032798terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
* 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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modafinil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sedation
- measure
- Pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.