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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT03078309 |
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Date of registration:
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10/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
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Scientific title:
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A Controlled Study of the Effect of Cannabis on Visual Functions in Healthy Subjects and in Retinitis Pigmentosa Patients |
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Date of first enrolment:
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September 1, 2018 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03078309 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).
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Phase:
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Early Phase 1
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Countries of recruitment
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Israel
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Contacts
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Name:
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Hadas Mechoulam, MD |
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Address:
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Telephone:
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972-2-6776397 |
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Email:
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Hadasm@gmail.com |
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Affiliation:
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Name:
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Hadas Mechoulam, MD |
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Address:
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Telephone:
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9293077002 |
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Email:
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hadasm@gmail.com |
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Affiliation:
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Name:
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Hadas Mechoulam, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Retinal Degeneration
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Retinitis Pigmentosa
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Cannabis
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Intervention(s)
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Drug: cannabis
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Primary Outcome(s)
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Electroretinogram (ERG) - acivity of the neural retina cone flicker latency
[Time Frame: 3 hours]
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Electroretinogram (ERG) - acivity of the neural retina mixed cone-rod response, cone flicker, rod response
[Time Frame: 3 hours]
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Secondary Outcome(s)
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Intra ocular pressure
[Time Frame: 3 hours]
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Macular thickness (OCT)
[Time Frame: 3 hours]
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Eye movements
[Time Frame: 3 hours]
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Titmus stereo eye movements
[Time Frame: 3 hours]
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Visual acuity
[Time Frame: 3 hours]
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Secondary ID(s)
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0007-17-HMO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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