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

NCT ID: NCT03078309

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinitis Pigmentosa Retinal Degeneration Cannabis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Electrophysiology will be analyzed by a blinded investigator.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

cannabis

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

cannabis

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cannabis

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cannabidiol THC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadas MECHOULAM

senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hadas Mechoulam, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hadas Mechoulam, MD

Role: CONTACT

9293077002

Hadas Lemberg, PhD

Role: CONTACT

00 972 2 6777572

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hadas Mechoulam, MD

Role: primary

972-2-6776397

Orly Harari

Role: backup

972-2-6777159

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24495949 (View on PubMed)

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. doi: 10.1016/j.jep.2004.03.029.

Reference Type BACKGROUND
PMID: 15182912 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 27930772 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0007-17-HMO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Functional Vision in TBI
NCT01214070 TERMINATED PHASE4