ADHDPhase 2NCT05219370
Treatment With Cannabis Oil Containing CBD, THC, CBDV or CBG vs. Placebo of Persons With ADHD
A Phase 2 study testing Cannabis oil in people with ADHD and Hyperactivity, run by Brlev Agricultural Crops Ltd at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD, Hyperactivity, Attention Deficit
- What is being tested?
- Cannabis oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Jul 2022to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- ADHD, Hyperactivity, Attention Deficit
- Being tested
- Cannabis oil
- Keywords
- medical cannabis
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oilDrug
administration of different cannabis oil types as compared with placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Cannabis oil |
| placebo | Placebo comparator | Placebo oil oral drops once daily. Titration from 0.3 to 1.8 ml/day during 21 days Receives: Drug: Cannabis oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30-35 days
Secondary outcomes (2)
to assess side effects and their severity using questionnaire
To examine whether cannabis oil side effects are tolerable and transient
Measured: 60 days
number of participants who dropped-out
to check whether drop out percentage is similar among groups
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start31 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Difficulties in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brlev Agricultural Crops Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Sciences Pharma Ltd.
- Responsible party
- Sponsor
- Investigators
- Mati Berkovitch, Principal investigator, Shamir (Assaf Harofeh) Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219370
- Sponsor's protocol ID
- 0232-19-ASF
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and Statistical Analysis Plan to be shared
Publications
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.
PubMed 25733754Cooper 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.
PubMed 28576350
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05219370
- Acronym / sponsor ID
- 0232-19-ASF
- Conditions
- ADHD, Hyperactivity, Attention Deficit
- Keywords
- medical cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brlev Agricultural Crops LtdIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Sciences Pharma Ltd.
- Study start
- 31 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| CBD rich | Experimental | Drug: Cannabis oilCannabis 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 |
| CBG rich | Experimental | Drug: Cannabis oilCannabis 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 |
| CBD & CBG rich | Experimental | Drug: Cannabis oilCannabis 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 |
| placebo | Placebo comparator | Drug: Cannabis oilPlacebo oil oral drops once daily. Titration from 0.3 to 1.8 ml/day during 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis oiladministration of different cannabis oil types as compared with placebo | Drug | CBD & CBG rich, CBD rich, CBG rich, placebo |
Primary outcome
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
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
2 secondary outcomes
to assess side effects and their severity using questionnaire
Time frame: 60 days
number of participants who dropped-out
Time frame: 60 days
Results and safety
The study was stopped early (reason given: Difficulties in enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Results publication: PubMed 25733754Thomas 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.
- Results publication: PubMed 28576350Cooper 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.
- Individual participant dataSharing planned: Yes. Study protocol and Statistical Analysis Plan to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mati Berkovitch principal investigator
Shamir (Assaf Harofeh) Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis oil in people with ADHD and Hyperactivity, run by Brlev Agricultural Crops Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of cannabis oil on ADHD symptoms as per TOVA test (time frame: 30-35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219370, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.