|- candidate number||15289|
|- NTR Number||NTR4123|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-aug-2013|
|- Secondary IDs||P13.143 NL45363.058.13|
|- Public Title||The influence of painkillers on ventilation when combined with alcohol|
|- Scientific Title||Alcohol and Oxycodone - The influence of the combination of alcohol and an opioid on ventilation in healthy young and elderly volunteers|
|- ACRONYM||the ‘A & O’ study|
|- hypothesis||It is hypothesized that respiratory depression from the opioid oxycodone will increase with concomitant administration of alcohol. Furthermore it is hypothesized that the increase in respiratory depression is not only dependent on the dosage of alcohol but dependent on age group as well.|
|- Healt Condition(s) or Problem(s) studied||Respiratory depression, Alcohol, Opioids , Oxycodone, Pain killers|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-sep-2013|
|- planned closingdate||1-feb-2013|
|- Target number of participants||24|
|- 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|
|- Primary outcome||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 outcome||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.
|- Timepoints||During 5.5h the subjects will be in the research lab, of which 3.5h the ethanol infusion will take place, once 20 mg oxycodon will be administered orally.
Five pain measurements will be done, five Vi-CO2 response curves will be done. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||A single-blind, crossover, 3-arm trial in healthy volunteers (phase I: 18-35 year, phase II: 65 years or older) to determine the influence of alcohol on opioid induced respiratory depression. Twelve subjects will be included in each phase of the study, who will have 3 experiment days with different ethanol concentrations (BrAC 0.0 g L-1, BrAC 0.5 g L-1, 1.0 g L-1) combined with oral administration of 20 mg oxycodon. The primary outcome is Vi-CO2 respirtory curved, secondary outcome is analgesia and sedation. |
|- Main changes (audit trail)|
|- RECORD||19-aug-2013 - 16-sep-2013|