Status:
TERMINATED
Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD
Lead Sponsor:
Brlev Agricultural Crops Ltd
Collaborating Sponsors:
Bio-Sciences Pharma Ltd.
Conditions:
ADHD
Hyperactivity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
ADHD is the most frequent neuro-developmental disorder in childhood and often continues into adolescence and adulthood. Indicated drug treatments for ADHD fall into 2 categories: stimulants (such as ...
Detailed Description
Participants will be screened by study staff for ADHD diagnosis and failure of conventional treatment. Participants passing the screening will undergo blood and urine tests, fill questionnaires, TOVA...
Eligibility Criteria
Inclusion
- Participants aged at least 18 y/o diagnosed with ADHD by Diagnostic and Statistical Manual of Mental Disorders (DSM)
- Participants with a lower than 0 TOVA score or with a higher than 0 score whom as per investigator opinion suffer from ADHD
- Participants who experienced treatment failure with more than one ADHD conventional drug
- Participants willing to attend all the visits in the trial.
Exclusion
- Participants who were treated with benzodiazepines, antihistamines, etc, in the week that preceded the trial start.
- Participants suffering from neurologic or psychiatric diseases
- Participants suffering from malignant diseases
- Participants suffering from syndromes or metabolic diseases
- Participants with significant clinical diagnosis that can damage the trial unfolding. The investigator may include them after the end of the situation which prevented their previous inclusion.
- Participants breastfeeding, pregnant or not willing to use contraceptives.
- Participants that will not adhere to the protocol as per investigator opinion
- Participants who weight less than 45 kg or more than 120kg or with BMI greater than 30
- Participants participating in another clinical trial which includes drug treatment
- Participants receiving any treatment for ADHD
- Participants using drugs
- Participants using cannabis or products containing cannabinoids, including medical cannabis.
Key Trial Info
Start Date :
July 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05219370
Start Date
July 31 2022
End Date
December 31 2022
Last Update
April 25 2023
Active Locations (1)
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1
Shamir (Assaf Harofeh) Medical Center
Be’er Ya‘aqov, Israel