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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53730
Enrollment
24
Registered
2022-06-21
Start date
2022-10-12
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ademdepressie oxycodone-induced respiratory depression respiratory depression

Interventions

Visit A: Oxycodone 10 mg tablet at t = 0 min + pregabaline 150 mg at t = 90 min
Visit B: Oxycodone 10 mg tablet at t = 0 min + lacosamide 150 mg at t = 90 min. Visit C (extra arm): Oxycodone 10 mg tablet at t = 0

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - aged 18-45 years, - body mass index

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Extrapolated ventilation at end-tidal PCO2 of 55 mmHg (VE55), 4-h following the intake of oxycodone.

Secondary

MeasureTime frame
(1) Level of sedation; (2) Relief of nociception; (3) Occurrence of nausea/vomiting; (4) pupil diameter; (5) baseline ventilation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)