The effect of Tetrahydrocannabinol on ocular hemodynamics in healthy subjects

Phase 1

• Conditions: The study will be carried out in healthy subjects.; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2017-004852-52-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

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

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): •Flicker induced increase in retinal blood flow<br> •Retinal vessel diameters<br> •Retinal blood velocities<br> •Retinal oxygen saturation<br> •THC plasma concentration<br><br> ;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.