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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified March 2017 by Hadas MECHOULAM, Hadassah Medical Organization
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
Hadas MECHOULAM, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT03078309
First received: February 10, 2017
Last updated: March 7, 2017
Last verified: March 2017
  Purpose

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 Intervention Phase
Retinitis Pigmentosa Retinal Degeneration Cannabis Drug: cannabis Early Phase 1

Study Type: Interventional
Study Design: 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.
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

Resource links provided by NLM:


Further study details as provided by Hadas MECHOULAM, Hadassah Medical Organization:

Primary Outcome Measures:
  • Electroretinogram - mixed cone-rod response, cone flicker, rod response [ Time Frame: 3 hours ]
    microvolt

  • Electroretinogram - cone flicker latency [ Time Frame: 3 hours ]
    milliseconds


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 3 hours ]
    LogMAR ETDRS

  • Titmus stereo eye movements [ Time Frame: 3 hours ]
    seconds of arc

  • Eye movements [ Time Frame: 3 hours ]
    degrees/second

  • Intra ocular pressure [ Time Frame: 3 hours ]
    mmHg

  • Macular thickness (OCT) [ Time Frame: 3 hours ]
    micrometers


Estimated Enrollment: 50
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03078309

Contacts
Contact: Hadas Mechoulam, MD 9293077002 hadasm@gmail.com
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
Investigators
Principal Investigator: Hadas Mechoulam, MD Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadas MECHOULAM, senior physician, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03078309     History of Changes
Other Study ID Numbers: 0007-17-HMO
Study First Received: February 10, 2017
Last Updated: March 7, 2017
Individual Participant Data (IPD) Sharing Statement:
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, Hadassah Medical Organization:
retinitis pigmentosa
retinal degeneration
cannabis
THC
CBD
electrophysiology
visual functions
eye
retina

Additional relevant MeSH terms:
Marijuana Abuse
Retinitis
Retinitis Pigmentosa
Retinal Degeneration
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 23, 2017