healthy volunteers R52.0
Conditions
Interventions
Group 1: Study participants receive a single oral dose of 20mg tetrahydrocannabinol.
Prior to administration of the study medication and 2 hours after administration a one hour-lasting MRI measurement
Sponsors
Klinikum der J.W.Goethe-Universität Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • Healthy men and women aged 18-50 years • Body mass index (BMI) in the range of 18 kg/m2 and 30 kg/m2 • unremarkable medical history, especially no heart and circulatory diseases, mental medical history • Healthy as determined by medical history, physical examination including vital signs and clinical laboratory test results • Women of childbearing age must be sterile or postmenopausal or must apply two appropriate measures of contraception (e.g. oral hormonal contraceptive plus intrauterine device) in accordance with Note 3 of the Note for guidance on non-clinical studies saftey for the Conduct of human clinical trials for pharmaceuticals (CPMP / ICH / 286 / 95 modification) (double contraception). • Signed informed consent after information about the benefits and risks of the trial and insurance
Exclusion criteria
Exclusion criteria: • Participation in another clinical study within the last 30 days before study • Simultaneous participation in another clinical trial • History or current evidence of abuse of any drug substance, licit or illicit, including alcohol (urine drug screen) • currently using of any prescription medication • Hypersensitivity to the active substance or any of the other ingredients • Epilepsy, a tendency to seizures • Cardiovascular diseases • Depression, bipolar disorder, schizophrenia and other psychiatric disorders in the medical history • impaired liver function • renal impairment • Pregnancy (positive pregnancy test in urine at “screening” or at the beginning of the study) and breast-feeding • Diseases or other criteria that make an MRI measurement impossible: • Pacemakers • neurostimulator or drug pump • Metal parts in the body (e.g. chips, clips or staples after surgery, including: metal fragments in the body) • claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of brain activation during nociceptive stimulation measured 2 hours after dronabinol application using functional magnetic resonance imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Topographic distribution of the fMRI brain responses to nociceptive stimulation under dronabinol | — |
Countries
Germany
Contacts
Public ContactCarmen Walter
Institut für Klinische Pharmakologie Klinikum der J.W. Goethe-Universität Frankfurt
Outcome results
None listed