The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
NCT ID: NCT03078309
Last Updated: 2021-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2018-09-01
2021-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
cannabis
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.
cannabis
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Interventions
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cannabis
single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* generally healthy with or without retinitis pigmentosa
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Hebrew University of Jerusalem
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
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Hadas MECHOULAM
senior physician
Principal Investigators
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Hadas Mechoulam, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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0007-17-HMO
Identifier Type: -
Identifier Source: org_study_id
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