Combined effect of Pregabaline and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers the POLO study

Phase 4

Completed

• Conditions: Ademdepressie; oxycodone-induced respiratory depression; respiratory depression

• Registration Number: NL-OMON53730
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2024-01-12
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- aged 18-45 years,
- body mass index < 30 kg.m-2,
- able to understand the written informed consent form,
- able to communicate with the staff,
- able and willing to complete the study procedures,
- signed the informed consent form,

Exclusion Criteria

- Presence or history of any medical or psychiatric disease (incl. a history of
substance abuse, anxiety, or the presence of a painful syndrome such as
fibromyalgia);
- Use of any medication in the three months prior to the study (incl.
paracetamol or other pain killers);
- Use of more than 21 alcohol units per week;
- A positive urinary drug test or a breath alcohol test at screening or on the
morning of the experiment;
- Pregnancy, lactating or a positive pregnancy test on the morning of the
experiment;
- Participation in another drug trial in the 60 days prior to dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified