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)

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) - Tianeptine study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47999

Enrollment

Registered

2019-01-07

Start date

2019-06-25

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

opiaat-geinduceerde ademdepressie opioid induced respiratory depressie

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers; Age: 18 - 40 years; Body mass index

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
minute ventilation	—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results