Healthy volunteers
Conditions
Interventions
Every participant will have two study days:
1. Placebo administration
2. Ketamine administration
ketamine will be given during 2 hours in two different concentrations. 20mg/70kg/h will be given the first hour and 40mg/70kg/h the second hour.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Healthy right handed male subjects naive to ketamine between 18 to 45 years old.
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI > 30); 2. Significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease; 3. History of illness, condition or medication use that, in the opinion of the investigator, might interfere with optimal participation, confound the results of the study or pose additional risk in administering S(+)-ketamine to the subject; 4. History of chronic alcohol or illicit drug use; 5. Unable to refrain from quinine containing products and grapefruit or grapefruit juice from 7 days prior to study start until the last study day; 6. Metal medical devices like pacemakers, knee or hip prosthesis, ear implants, vessel clips, subcutaneous insulin pumps or carries metal particles (e.g. metal splinter in the eye) inside the body; 7. Claustrophobia; 8. Allergy to study medications; 9. Not able to maintain a regular diurnal rhythm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Functional MRI; 2. Pain scores; 3. Ketamine blood concentration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nausea and vomiting; 2. Psychomimetic side effects; 3. Saliva cortisol measurements. | — |
Contacts
Public ContactAlbert Dahan
Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600
Outcome results
None listed