The study will be carried out in healthy subjects.
Conditions
Interventions
Product Name: Dronabinol
Pharmaceutical Form: Capsule
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Concentration unit: mg milli
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women aged between 18 and 35 years • Normal ophthalmic findings • Ametropia = 6 diopters • Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant • Normal findings in the laboratory testing unless the investigator considers an abnormality to be clinically irrelevant • Nonsmokers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Regular use of medication, abuse of alcoholic beverages or drugs • History of drug or alcohol abuse • Psychiatric disorders in the medical history • Risk for drug dependence as evaluated by a psychiatrist • Participation in a clinical trial in the 3 weeks preceding the study • Positive urine drug test at the screening examination or on the study days • Positive alcohol breath test at the screening examination or on the study days • Regular consumption of cannabis and inability to not consume cannabis during the study period • Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives) • Symptoms of a clinically relevant illness in the 3 weeks before the first study day • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs • Blood donation during the previous 3 weeks • Known hypersensitivity to any of the components of the IMP under investigation or other study medication • History or family history of epilepsy • Pregnant or breast-feeding women • Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of single administration of Tetrahydrocannabinol (THC) on ocular blood flow and its regulation.;Secondary Objective: not applicable;Primary end point(s): Optic nerve head blood flow;Timepoint(s) of evaluation of this end point: Since this is a cross-over study, optic nerve head blood flow will be assessed on both study days before and after administration of dronabinol or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Flicker induced increase in retinal blood flow • Retinal vessel diameters • Retinal blood velocities • Retinal oxygen saturation • THC plasma concentration ;Timepoint(s) of evaluation of this end point: Since this is a cross-over study, secondary end points will be assessed on both study days before and after administration of dronabinol or placebo. | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed