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NCT03907163

The Effect of Tetrahydrocannabinol on Ocular Hemodynamics in Healthy Subjects

Completed NA Last updated 10 April 2019
What this trial tests

NA trial testing Dronabinol in Retinal Blood Flow in 24 participants. Completed in 27 November 2018.

Timeline
2 July 2018
Primary endpoint
27 November 2018
27 November 2018

Quick facts

Lead sponsorMedical University of Vienna
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposediagnostic
Enrollment24
Start date2 July 2018
Primary completion27 November 2018
Estimated completion27 November 2018
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 35, any sex, with Retinal Blood Flow. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Glaucoma is among the leading causes for irreversible blindness worldwide. While lowering intraocular pressure (IOP) remains the mainstay of therapy, there are still some patients who progress despite wellcontrolled IOP. There is evidence from several studies that ocular blood flow and its regulation is impaired in patients with glaucoma. Tetrahydrocannabinol (THC) has been used in the treatment for glaucoma in some countries for several years due to its IOP lowering effect. In addition, there is also evidence that THC features neuroprotective effects and improves ocular hemodynamics. Dronabinol is a synthetic THC that is legally available in several European countries. It has the advantage that exact dosing of THC is possible in contrast to previously applied administration forms such as smoking. Due to its legal status in the past, data about the effect of THC on ocular blood flow and its regulation are sparse. This holds true for basic research in healthy subjects as well as in patients with glaucoma.The aim of the present study therefore is to investigate whether single administration of THC alters optic nerve head (ONH) blood flow in healthy subjects. In addition, other parameters for ocular blood flow will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling. The study will be conducted in a randomized, double-masked, placebocontrolled, two-way cross-over design. Subjects will receive 5mg dronabinol on one study day. This dose is the recommended starting dose for some indications in clinical practice. Other studies investigating retinal hemodynamics or IOP after administration of THC also have used similar or slightly higher doses.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Dronabinol

Trials testing the same drug.

Other recruiting trials for Retinal Blood Flow

Currently open trials in the same condition.

Other Medical University of Vienna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03907163.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing