The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients

February 11, 2021 updated by: Hadas MECHOULAM, Hadassah Medical Organization

A Controlled Study of the Effect of Cannabis on Visual Functions in Healthy Subjects and in Retinitis Pigmentosa Patients

Medical Marijuana is used widely, and its effects on the visual system and the function of the retina have not been investigated thoroughly. Some evidence suggests that cannabinoids may be beneficial in certain degenerative diseases of the retina.

The purpose of the study is

  1. To determine whether cannabis derivatives affect the visual functions in healthy adults
  2. To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Twenty five healthy subjects and 25 retinitis pigmentosa patients will be recruited and will sign an informed consent form. An initial eye exam will include visual acuity and stereo vision, eye movements and eye movement recording, a full slit lamp eye exam, intra-ocular pressure measurement, visual field, OCT and electrophysiology. The subjects will receive a single sublingual dose of cannabis (THC:CBD 1:1, THC 5 mg, or THE:CBD 1:40, THC 5 mg), and will undergo the above examination again. Subjects will be monitored for 5 hours after the administration of cannabis.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • consenting adults
  • generally healthy with or without retinitis pigmentosa

Exclusion Criteria:

  • chronic or acute disease other than retinitis pigmentosa
  • use of medication
  • congestive heart failure
  • recent use of illicit drugs (past month)
  • history of drug dependency
  • history of psychiatric disorder in subject or immediate relatives
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy
All subjects will undergo a full ocular exam and visual functions will be assessed before and after the administration of a single dose of cannabis (THC:CBD 1:40). On the second study day all subjects will receive a single dose of cannabis (THC:CBD 1:1) and undergo the full ocular exam again.
Drug: cannabis
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Other Names:
  • cannabidiol
  • THC
Experimental: Retinitis Pigmentosa
All subjects will undergo a full ocular exam and visual functions will be assessed before and after the administration of a single dose of cannabis (THC:CBD 1:40). On the second study day all subjects will receive a single dose of cannabis (THC:CBD 1:1) and undergo the full ocular exam again.
Drug: cannabis
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Other Names:
  • cannabidiol
  • THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response
Time Frame: 3 hours
microvolt
3 hours
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency
Time Frame: 3 hours
milliseconds
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 3 hours
LogMAR ETDRS
3 hours
Titmus stereo eye movements
Time Frame: 3 hours
seconds of arc
3 hours
Eye movements
Time Frame: 3 hours
degrees/second
3 hours
Intra ocular pressure
Time Frame: 3 hours
mmHg
3 hours
Macular thickness (OCT)
Time Frame: 3 hours
micrometers
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Hebrew University of Jerusalem

Investigators

  • Principal Investigator: Hadas Mechoulam, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0007-17-HMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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