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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03078309
• Other study ID #: 0007-17-HMO
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Hadassah Medical Organization
• Contact: Hadas Mechoulam, MD
• Phone: 9293077002
• Email: hadasm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse
• Retinal Degeneration
• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Lax P, Esquiva G, Altavilla C, Cuenca N. Neuroprotective effects of the cannabinoid agonist HU210 on retinal degeneration. Exp Eye Res. 2014 Mar;120:175-85. doi: 10.1016/j.exer.2014.01.019. Epub 2014 Feb 1. — View Citation

Lyons CJ, Robson AG. Retinal Ganglion Cell Dysfunction in Regular Cannabis Users: Is the Evidence Strong Enough to Consider an Association? JAMA Ophthalmol. 2017 Jan 1;135(1):60-61. doi: 10.1001/jamaophthalmol.2016.4780. — View Citation

Russo EB, Merzouki A, Mesa JM, Frey KA, Bach PJ. Cannabis improves night vision: a case study of dark adaptometry and scotopic sensitivity in kif smokers of the Rif mountains of northern Morocco. J Ethnopharmacol. 2004 Jul;93(1):99-104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response	microvolt	3 hours
Primary	Electroretinogram (ERG) - acivity of the neural retina cone flicker latency	milliseconds	3 hours
Secondary	Visual acuity	LogMAR ETDRS	3 hours
Secondary	Titmus stereo eye movements	seconds of arc	3 hours
Secondary	Eye movements	degrees/second	3 hours
Secondary	Intra ocular pressure	mmHg	3 hours
Secondary	Macular thickness (OCT)	micrometers	3 hours