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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05219370
• Other study ID #: 0232-19-ASF
• Status: Terminated
• Phase: Phase 2
• Start date: July 31, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Brlev Agricultural Crops Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit
• Hyperactivity
• Marijuana Abuse

Intervention

Drug:
• Cannabis oil
administration of different cannabis oil types as compared with placebo

Locations

Country	Name	City	State
Israel	Shamir (Assaf Harofeh) Medical Center	Be'er Ya'aqov

Sponsors (2)

Lead Sponsor	Collaborator
Brlev Agricultural Crops Ltd	Bio-Sciences Pharma Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Cooper RE, Williams E, Seegobin S, Tye C, Kuntsi J, Asherson P. Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial. Eur Neuropsychopharmacol. 2017 Aug;27(8):795-808. doi: 10.1016/j.euroneuro.2017.05.005. Epub 2017 May — View Citation

Thomas R, Sanders S, Doust J, Beller E, Glasziou P. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015 Apr;135(4):e994-1001. doi: 10.1542/peds.2014-3482. Epub 2015 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of cannabis oil on ADHD symptoms as per TOVA test	To assess if participants treated with cannabis oil show an improvement in TOVA scores	30-35 days
Primary	efficacy of cannabis oil on ADHD symptoms as per Conners questionnaire	To assess if participants treated with cannabis oil show an improvement in Conners score	30-35 days
Secondary	to assess side effects and their severity using questionnaire	To examine whether cannabis oil side effects are tolerable and transient	60 days
Secondary	number of participants who dropped-out	to check whether drop out percentage is similar among groups	60 days