Opioid induced respiratory depression
Conditions
Interventions
Intravenous intervention of ethanol inducing a steady state BrAC-level (0.5 g L-1 or 1.0 g L-1)
Oral administration of Oxycodone 20 mg IRS
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects a. aged 18-40 years (phase I) b. aged 65 years or older (phase II) 2. Body Mass Index 18-30 mm/kg2 3. Subject is able to read and understand the written consent form, complete study‐related procedures, and communicate with the study staff. 4. Healthy and free of significant abnormal findings as determined by medical history, physical examination and vital signs. 5. Subject is deemed suitable by the Investigator for inclusion in the study
Exclusion criteria
Exclusion criteria: 1. Current diagnosis or history of psychiatric disease. 2. Elderly volunteers should have no cognitive impairment defined as a Mini Mental State Examination (MMSE) score: < 28. 3. Current or chronic medical condition requiring the use of medication considered Cytochrome P-450 (CYP2E1, CYP2D6, CYP3A4) inductor or current use of opioid analgesics. 4. Current diagnosis or history of lung disease ( i.e. asthma, COPD, tuberculosis,). 5. Exclusion based on medication use is subject to judgment by investigators. 6. Participation in a clinical drug study during the 60 days preceding the initial dosing of this study. 7. Any history of frequent nausea or vomiting regardless of etiology 8. Weekly alcohol intake exceeding the equivalent of 21 units/week or a positive alcohol breath test during check-in 9. Asian ethnicity 10. Pregnancy ascertained by positive urine pregnancy test on dosing day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A shift of the Vi-CO2 response curves measured pre-dose, during alcohol clamp, two times after adminstration of oxycodone and comcomitant administration of alcohol and one after discontinuation of alcohol administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess whether sedation as measured by VAS scale and BIS monitoring is increased in the alcohol conditions compared to the no alcohol condition. 2. To asess whether anagelsia induceed by oxycodone is affected by alcohol. | — |
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600
Outcome results
None listed