Alcohol and Oxycodone - The influence of the combination of alcohol and an opioid on ventilation in healthy young and elderly volunteers - the 'A&O' study

Recruiting

Conditions: Opioid geinduceerde ademhalingsdepressie
Respiratory depression and reduced breathing

Registration Number: NL-OMON40452

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Healthy sybjects
- Aged 18-40 years (phase I)
- Aged 65 years or older (phase II)
- Body Mass Index 18-35 mm/kg2
- Subject is able to read and understand the written consent form, complete study related procedures and communicate with the study staff
- Healthy and free of significant abnormale findings as determined by medical history, physical examination and vital signs. For the elderly volunteers no abnormal findings for kidney and liver function on laboratory tests.
- Subject is deemed suitable by the Investigator for inclusion in the study

Exclusion Criteria

Current diagnosis or history of psychiatric disease
Current or chronic medical condition requiring the medication considered Cytochrome P-450 (CYP2E1, CYP2D6, CYP3A4) inductor or current use of opioid analgesics
Current diagnosis or history of lung disease (i.e. asthma, COPD, tuberculosis)
Exclusion based on medication use is subject to jugdment by investigators
Participation in a clinical drug study during the 60 days preceding the initial dosing of this study
Any history of frequent nausea or vomiting regardles of etiology
Weekly alcohol intake exceeding the equivalent of 21 units/week or positive alcohol breath test during check-in
Asian ethnicity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A shift of the Vi*CO2 response curves measured pre-dose, during alcohol clamp,<br /><br>two times after administration of oxycodone and concomitant adminstration of<br /><br>alcohol and one after discontinuation of alcohol administration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To assess whether sedation as measured by a VAS scale and BIS monitoring is<br /><br>increased in the alcohol conditions compared to the no alcohol condition.</p><br>