Placebo controlled fMRT assessment of the effects of the cannabinoid receptor agonist dronabinol (THC) on pain associated brain activation

Klinikum der J.W.Goethe-Universität Frankfurt0 个研究点目标入组 30 人开始时间: 2010年6月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

Klinikum der J.W.Goethe-Universität Frankfurt