NCT05219370

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

December 30, 2021

Last Update Submit

April 23, 2023

Conditions

ADHDHyperactivityAttention Deficit

Keywords

medical cannabis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • to assess side effects and their severity using questionnaire

    60 days

  • number of participants who dropped-out

    60 days

Study Arms (4)

CBD rich

EXPERIMENTAL

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

CBG rich

EXPERIMENTAL

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

CBD & CBG rich

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

Placebo oil oral drops once daily. Titration from 0.3 to 1.8 ml/day during 21 days

Drug: Cannabis oil

Interventions

Cannabis oilDRUG

administration of different cannabis oil types as compared with placebo

CBD & CBG richCBD richCBG richplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir (Assaf Harofeh) Medical Center

Be’er Ya‘aqov, Israel

Location

Related Publications (2)

  • 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.

    PMID: 25733754RESULT

  • 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 30.

    PMID: 28576350RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mati Berkovitch

    Shamir (Assaf Harofeh) Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
the responsible pharmacist is un-blinded
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2021

First Posted

February 2, 2022

Study Start

July 31, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Study protocol and Statistical Analysis Plan to be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
during all the trial
Access Criteria
interested colleagues

Locations

IL(1)