NCT03078309

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. 1.To determine whether cannabis derivatives affect the visual functions in healthy adults
  2. 2.To examine the effect of cannabis derivatives on the retina of retinitis pigmentosa patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2018

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

February 10, 2017

Last Update Submit

February 11, 2021

Conditions

Retinitis PigmentosaRetinal DegenerationCannabis

Keywords

retinitis pigmentosaretinal degenerationcannabisTHCCBDelectrophysiologyvisual functionseyeretina

Outcome Measures

Primary Outcomes (2)

  • Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response

    microvolt

    3 hours

  • Electroretinogram (ERG) - acivity of the neural retina cone flicker latency

    milliseconds

    3 hours

Secondary Outcomes (5)

  • Visual acuity

    3 hours

  • Titmus stereo eye movements

    3 hours

  • Eye movements

    3 hours

  • Intra ocular pressure

    3 hours

  • Macular thickness (OCT)

    3 hours

Study Arms (2)

healthy

EXPERIMENTAL

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

Retinitis Pigmentosa

EXPERIMENTAL

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

Interventions

cannabisDRUG

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

Also known as: cannabidiol, THC
Retinitis Pigmentosahealthy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consenting adults
  • generally healthy with or without retinitis pigmentosa

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

Related 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.

    PMID: 24495949BACKGROUND

  • 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.

    PMID: 15182912BACKGROUND

  • 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.

    PMID: 27930772BACKGROUND

MeSH Terms

Conditions

Retinitis PigmentosaRetinal DegenerationMarijuana Abuse

Interventions

nabiximolsCannabidiolDronabinol

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Hadas Mechoulam, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Mechoulam, MD

CONTACT

9293077002hadasm@gmail.com

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Electrophysiology will be analyzed by a blinded investigator.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

February 10, 2017

First Posted

March 13, 2017

Study Start

September 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)