MedTrace Logo

The Effect of Tetrahydrocannabinol on Ocular Hemodynamics in Healthy Subjects

NCT03907163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-10

No results posted yet for this study

Summary

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.

Conditions

  • Retinal Blood Flow

Interventions

DRUG

Dronabinol

Capsules containing 5 mg Dronabinol

OTHER

Placebo

capsules identical in appearance to dronabinol

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2018-11-27
Completion
2018-11-27

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907163 on ClinicalTrials.gov