Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in healthy volunteers

This observational invasive study (n=12) was conducted by Leiden University Medical Centre (LUMC). The study aimed to obtain the pharmacokinetic parameters of S(+)-ketamine and study its pharmacodynamic effects on experimental pain. The primary outcome measures included Cp S(+)-ketamine and pain relief as tested by electrical and heat pain models.

Secondary outcomes involved EEG, ECG, and blood pressure assessments. S(+)-ketamine is a form of ketamine known for its analgesic properties with fewer psychomimetic side effects. The study focused on healthy volunteers, with the design being a placebo-controlled, single-blind, randomized cross-over.

The ethical review status is not available, and the study has been completed. Potential risks included nausea, psychomimetic side effects, and bruising due to arterial line placement. Contacts for the study were based at Leids Universitair Medisch Centrum in the Netherlands.

Topic Healthy Subjects
Compound Ketamine Placebo
Country Netherlands
Visit trial
Status Completed
Results Published No
Start date 10 September 2007
End date 01 January 2010
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 12
Sex All
Age 18-
Therapy No

Trial Details

Aims of the study: 1) To obtain pharmacokinetic parameters of S(+)-ketamine; 2) To study the pharmacodynamic effects of intravenous S(+)-ketamine on experimental pain;

Trial Number 2006-002979-40-NL

Sponsors & Collaborators

Leiden University
Leiden University Medical Center is doing several studies into psychedelics. They do this in cooperation with other universities (e.g. Utrecht University) and companies (e.g. COMPASS).

Data attribution

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