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Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05219370
Recruitment Status : Terminated (Difficulties in enrollment)
First Posted : February 2, 2022
Last Update Posted : April 25, 2023
Sponsor:
Collaborator:
Bio-Sciences Pharma Ltd.
Information provided by (Responsible Party):
Brlev Agricultural Crops Ltd

Study Description
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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 methylphenidate and amphetamines) and non-stimulants (such as atomoxetine, guanfacine and clonidine) but some persons cannot tolerate their secondary effects or find them non-effective.

In the last decade, medical cannabis products have been researched as possible treatment for neurological and mental diseases such as: Post trauma disorder (PTD), autism (ASD), epilepsy, fibromyalgia (FM) and more.

Data on the effects of cannabidiol rich cannabis extract use for ADHD seems promising but is still limited. The aim of this study is to investigate if oral cannabinoids given to adults with ADHD affect the symptoms of the disorder.

The main objectives of the study are: 1) to characterize the effects of treatment with cannabis oil on symptoms of ADHD; 2) to compare safety and efficacy of cannabis oil products with different CBD,Cannabidivarin (CBDV), cannabigerol (CBG) and THC ratio; 3) and to measure endocannabinoids, THC and CBD and metabolites levels in the blood of the participants.

In this study, participants diagnosed with ADHD will be treated with canabidiol-rich cannabis oil and will follow up weekly during approx.1 month (the study period). Blood tests will be performed before and after treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and their metabolites. Test of Variables of Attention test (TOVA) will be administrated before and after treatment


Condition or disease Intervention/treatment Phase
ADHD Hyperactivity Attention Deficit Drug: Cannabis oil Phase 2

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 test and will be randomized to one of the 4 arms.

Participants will receive the drug, be instructed as per dose titration and as per danger of driving under drug influence.

Telephone follow up will take place weekly after 7 days from starting. Participants will guess to which arm the participant was allocated to after 2 weeks of treatment .

Participants will arrive for a last visit, fill questionnaires, do TOVA test and undergo blood and urine tests.

Participants will be contacted over the phone for a last time, after treatment completion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: each participant will be randomized to one of the 4 arms and will receive the treatment for 32 days. Follow up till 6 weeks from starting
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: the responsible pharmacist is un-blinded
Primary Purpose: Treatment
Official Title: Treatment With Cannabis Oil Containing Canabidiol (CBD) Tetrahydrocannabinol (THC), Cannabidivarin (CBDV) or Cannabigerol (CBG) vs. Placebo of Persons Diagnosed With ADHD After Failure of Conventional Treatment
Actual Study Start Date : July 31, 2022
Actual Primary Completion Date : December 31, 2022
Actual Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: CBD rich
Cannabis oil oral drops containing 95 mg/ml CBD; 5 mg/ml THC; 15 mg/ml CBDV ; no CBG, once daily Titration from 0.3 to 1.8 ml/day during 21 days
 Drug: Cannabis oil
administration of different cannabis oil types as compared with placebo
Experimental: CBG rich

Cannabis oil oral drops containing no CBD; 5 mg/ml THC; no CBDV; 95 mg/ml CBG, once daily.

Titration from 0.3 to 1.8 ml/day during 21 days

 Drug: Cannabis oil
administration of different cannabis oil types as compared with placebo
Experimental: CBD & CBG rich

Cannabis oil oral drops containing 47.5 mg/ml CBD; 2.5 mg/ml THC; 7.5 mg/ml CBDV; 47.5 mg/ml CBG, once daily.

Titration from 0.3 to 1.8 ml/day during 21 days

 Drug: Cannabis oil
administration of different cannabis oil types as compared with placebo
Placebo Comparator: placebo
Placebo oil oral drops once daily. Titration from 0.3 to 1.8 ml/day during 21 days
 Drug: Cannabis oil
administration of different cannabis oil types as compared with placebo


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of cannabis oil on ADHD symptoms as per TOVA test [ Time Frame: 30-35 days ]
    To assess if participants treated with cannabis oil show an improvement in TOVA scores

  2. efficacy of cannabis oil on ADHD symptoms as per Conners questionnaire [ Time Frame: 30-35 days ]
    To assess if participants treated with cannabis oil show an improvement in Conners score


Secondary Outcome Measures :
  1. to assess side effects and their severity using questionnaire [ Time Frame: 60 days ]
    To examine whether cannabis oil side effects are tolerable and transient

  2. number of participants who dropped-out [ Time Frame: 60 days ]
    to check whether drop out percentage is similar among groups


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219370


Locations
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Israel
Shamir (Assaf Harofeh) Medical Center
Be'er Ya'aqov, Israel
Sponsors and Collaborators
Brlev Agricultural Crops Ltd
Bio-Sciences Pharma Ltd.
Investigators
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Principal Investigator: Mati Berkovitch Shamir (Assaf Harofeh) Medical Center
  Study Documents (Full-Text)

Documents provided by Brlev Agricultural Crops Ltd:
Study Protocol and Statistical Analysis Plan  [PDF] August 16, 2021

More Information
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Publications of Results:

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Responsible Party: Brlev Agricultural Crops Ltd
ClinicalTrials.gov Identifier: NCT05219370    
Other Study ID Numbers: 0232-19-ASF
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol and Statistical Analysis Plan to be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: during all the trial
Access Criteria: interested colleagues

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brlev Agricultural Crops Ltd:
medical cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders