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

Hadassah Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Cannabis; Retinal Degeneration; Retinitis Pigmentosa

Treatments: Drug: cannabis

Study type: Interventional

Funder types: Other

Identifiers

NCT03078309

0007-17-HMO

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

healthy

Experimental group

Description:

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.

Treatment:

Drug: cannabis

Retinitis Pigmentosa

Experimental group

Description:

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.

Treatment:

Drug: cannabis