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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03078309
Enrollment
50
Registered
2017-03-13
Start date
2018-09-01
Completion date
2021-12-31
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis, Retinal Degeneration, Retinitis Pigmentosa

Keywords

retinitis pigmentosa, retinal degeneration, cannabis, THC, CBD, electrophysiology, visual functions, eye, retina

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.

Interventions

DRUGcannabis

single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)

Sponsors

Hebrew University of Jerusalem
CollaboratorOTHER
Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

Electrophysiology will be analyzed by a blinded investigator.

Intervention model description

Arm 1 - healthy subjects. Arm 2 - subjects with 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response3 hoursmicrovolt
Electroretinogram (ERG) - acivity of the neural retina cone flicker latency3 hoursmilliseconds

Secondary

MeasureTime frameDescription
Eye movements3 hoursdegrees/second
Visual acuity3 hoursLogMAR ETDRS
Macular thickness (OCT)3 hoursmicrometers
Intra ocular pressure3 hoursmmHg
Titmus stereo eye movements3 hoursseconds of arc

Countries

Israel

Contacts

Primary ContactHadas Mechoulam, MD
hadasm@gmail.com9293077002
Backup ContactHadas Lemberg, PhD
lhadas@hadassah.org.il00 972 2 6777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026