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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03078309
• Collaborator: Hebrew University of Jerusalem (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Retinitis Pigmentosa; Retinal Degeneration; Cannabis	Drug: cannabis	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: Electrophysiology will be analyzed by a blinded investigator.
• Primary Purpose: Basic Science
• Official Title: A Controlled Study of the Effect of Cannabis on Visual Functions in Healthy Subjects and in Retinitis Pigmentosa Patients
• Actual Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response [3 hours]

   microvolt

2. Electroretinogram (ERG) - acivity of the neural retina cone flicker latency [3 hours]

   milliseconds

Secondary Outcome Measures

1. Visual acuity [3 hours]

   LogMAR ETDRS

2. Titmus stereo eye movements [3 hours]

   seconds of arc

3. Eye movements [3 hours]

   degrees/second

4. Intra ocular pressure [3 hours]

   mmHg

5. Macular thickness (OCT) [3 hours]

   micrometers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Center	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization
• Hebrew University of Jerusalem

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Hadas MECHOULAM, senior physician, Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT03078309
• Other Study ID Numbers: 0007-17-HMO
• First Posted: Mar 13, 2017
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hadas MECHOULAM, senior physician, Hadassah Medical Organization: retinitis pigmentosa; retinal degeneration; cannabis; THC; CBD; electrophysiology; visual functions; eye; retina
• Additional relevant MeSH terms: Retinitis; Retinitis Pigmentosa; Retinal Degeneration; Marijuana Abuse; Cannabidiol

Study Results

No Results Posted as of Feb 12, 2021