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

April 23, 2023 updated by: Brlev Agricultural Crops Ltd

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel
        • Shamir (Assaf Harofeh) Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30-35 days
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
30-35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess side effects and their severity using questionnaire
Time Frame: 60 days
To examine whether cannabis oil side effects are tolerable and transient
60 days
number of participants who dropped-out
Time Frame: 60 days
to check whether drop out percentage is similar among groups
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brlev Agricultural Crops Ltd

Collaborators

Bio-Sciences Pharma Ltd.

Investigators

  • Principal Investigator: Mati Berkovitch, Shamir (Assaf Harofeh) Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0232-19-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and Statistical Analysis Plan to be shared

IPD Sharing Time Frame

during all the trial

IPD Sharing Access Criteria

interested colleagues

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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