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

Early Phase 1

• Conditions: Cannabis; Retinal Degeneration; Retinitis Pigmentosa
• Interventions: Drug: cannabis

• Registration Number: NCT03078309
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2018-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy	cannabis	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.
Retinitis Pigmentosa	cannabis	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.

Primary Outcome Measures

Name	Time	Method
Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response	3 hours	microvolt
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency	3 hours	milliseconds

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel