The effect of intravenous tianeptine on an established model of opioid-induced respiratory depression (OIRD) in healthy volunteers: a population pharmacokinetic and pharmacodynamic study (the Tianeptine study)

Completed

• Conditions: opiaat-geinduceerde ademdepressie; opioid induced respiratory depressie

• Registration Number: NL-OMON47999
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-01-13
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Healthy male or female volunteers;
Age: 18 - 40 years;
Body mass index < 30 kg/m2;
Able to give informed consent.

Exclusion Criteria

Known or suspected neuromuscular or a (family) history of any neuromuscular
disease;
A history of allergic reaction to food or medication including study medication;
Any current or previous medical (including high blood pressure), neurological
or psychiatric illness (including a history of anxiety);
Alcohol abuse (> 21 units/week);
History of ingestion/administration of opioids within the past 30 days;
Illicit drug use in the past 30 days before inclusion;
Pregnancy or lactation;
Participation in any medical or drug trial in the month prior to the current
study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>minute ventilation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>None</p><br>