Attention Deficit Hyperactivity Disorder (ADHD)Phase 2NCT06542445
The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
A Phase 2 study testing Oral CBD oil enriched with terpenes in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Bazelet Nehushtan LtD. at 1 site in Israel.
Trial summary
ADHD is the most frequent neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adolescence and adulthood. The disorder is marked by age-inappropriate inattention, hyperactivity, and impulsivity. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Oral CBD oil enriched with terpenes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Aug 2024to 22 Sep 2026
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
- Willing/able to arrive to all the necessary visits as per study protocol.
Who cannot join
- Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
- Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.
- Participants suffering from neurological or psychiatric diseases.
- Participants suffering from neoplastic diseases.
- Participants with syndromes or metabolic diseases.
- Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
Show all 26Show fewer
- Pregnant or breastfeeding adolescents.
- Sexually active female adolescents who are unwilling to use contraceptives.
- Participants that in the PI opinion will not comply with the protocol in a way that will harm the study (for ex.: not using contraceptives.)
- Participants with less than 18 kg or more than 90 kg weight.
- Participants with BMI lower than 18 or higher than 29.9.
- Participants engaged in another clinical study which includes a medicine.
- Participants engaged in another study regarding ADHD treatment of any kind.
- Participants using alcohol or drugs.
- Past or present use of Cannabis, including medical cannabis
- Criteria for early termination:
- Use of another medication for ADHD during the study.
- Use of a medication from the exclusion criteria list during the study.
- Use of alcohol or drugs during the study.
- Participants who got pregnant during the study.
- Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days.
- Participants who did not start the treatment during the 14 days from receiving the drug.
- Non -compliant participants.
- Criteria for exchange:
- PI may exchange participants that quit, if they did not start treatment for new participants.
- PI may recruit again participants who quit after a new full recruitment process.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir Medical Center
Tsrifin
Ariela Hazan, +97289778465, arielah@shamir.gov.il
Elkana Kohn, PhD, +97289542181, elkanak@shamir.gov.il
About this study
Official title: The Safety and Efficacy of Treatment With Cannabidiol (CBD) Oil Enriched With Terpenes, Devoid of THC, in Children Diagnosed With ADHD
ADHD is the most frequent neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adolescence and adulthood. The disorder is marked by age-inappropriate inattention, hyperactivity, and impulsivity. Drug treatments for ADHD include stimulants containing methylphenidate (like Ritalin and Concerta) or amphetamines (like Vyvanse). However, 30-35% of the patients do not respond well to these treatments, and stimulants may result with various side effects.
The use of medical cannabis increases; applied for expending medical conditions, with growing evidence for its beneficial effects. A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity.
Read more
The current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil (devoid of THC), enriched with terpenes. Participants will be randomly assigned to receive either the enriched CBD oil or a placebo, for 5 weeks (Treatment, Stage I).
At the end of the treatment stage (I), an open-label stage will follow (II), wherein, all participants will receive the investigational product for an additional 5 weeks.
The investigators hypothesize that children treated with the enriched CBD oil (Treatment, Stage I) will show significantly higher improvement in hyperactivity and inattention scores, as compared with the placebo group.
Read the detailed description
Screening phase:
Parents who are interested to take part in study, will contact the study team. Parents will be asked to provide documents attesting their child's medical status and forms required to process a medical cannabis prescription.
Visit 1 - Baseline:
- Participants and parents will sign an Informed Consent Form.
- Parents will complete questionnaires about the child's health, clinical history, medications, sleep, eating habits, and quality of life.
- Participants will be examined by a pediatrician, who will fill out a physical examination report, including height, weight and blood pressure, and will conduct an urine test.
- Participants will conduct a TOVA (Test of Variables of Attention) test, and answer a CBCL (Child Behavior Checklist) questionnaire.
- Parents and teachers will complete the Conners questionnaires (sent during the screening phase. Conners questionnaires may be filled out prior to Visit 1, but no longer than two weeks prior to Visit 1).
- Participants and parents will receive the study drug/placebo and usage instructions.
Treatment using the study drug (Stage I) will be initiated following Visit 1, according to a schedule set by the study team.
Follow-up 1:
The study team will contact the parents via a phone call two weeks (±2 days) after initiation of stage I. Parents will answer questions regarding general health and side effects.
Visit 2 -at the end of Stage I:
- Five weeks (±3 days) after initiation of stage I.
- Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1.
- All participants will receive new bottles of the investigational product - the CBD oil enriched with terpenes (open label, Stage II).
Follow-up 2:
- The study team will contact the parents via a phone call two weeks (±2 days) after initiation of Stage II. Parents will answer questions regarding general health and side effects.
Visit 3 - at the end of Stage II:
- Five weeks (±3 days) after initiation of stage II.
- Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1, excluding the TOVA test.
- Study drugs' bottles and cannabis use prescription will be returned to the study team.
- Being tested
- Oral CBD oil enriched with terpenes, Oral Placebo
- Keywords
- Cannabidiol, Terpenes, Medical Cannabis, Attention Deficit Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CBD oil enriched with terpenesDrug
Stage I dosing, increasing titration:
days 1-2: 2.5 mg/kg BW/day; days 3-4: 5 mg/kg BW/day; day 5-7: 7.5 mg/kg BW/day; days 8-35: 10 mg/kg BW/day.
Stage II dosing, increasing titration:
days 36-37: 2.5 mg/kg BW/day; days 38-39: 5 mg/kg BW/day; day 40-42: 7.5 mg/kg BW/day; days 43-70:10 mg/kg BW/day.
Oral PlaceboDrug
Oral placebo oil that is similar in appearance and taste to the CBD oil. Titration and dosing identical to those described for the CBD oil.
| Study group | Role | What they receive |
|---|---|---|
| CBD oil enriched with terpenes | Active comparator | 24% CBD, terpenes, MCT oil. Receives: Drug: Oral CBD oil enriched with terpenes |
| Placebo oil | Placebo comparator | fragrances and flavors, MCT oil. Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Conners' Parent Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Conners' Parent Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Secondary outcomes (10)
Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.
Conners' Parent Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.
Computerized visual T.O.V.A
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.
Computerized visual T.O.V.A
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in TOVA test - Total score, as compared with baseline.
Computerized visual T.O.V.A
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline.
Conners' Teacher Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in inattentiveness sub-score of the Conners' Teacher Questionnaire, as compared with baseline
Conners' Teacher Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in Conners' Teacher Questionnaire - Total score, as compared with baseline.
Conners' Teacher Rating Scale
Measured: 5 weeks (Visit 1 to Visit 2)
Improvement in the scores of CBCL questionnaire, as compared with baseline.
Child Behavior Checklist (CBCL)
Measured: 5 weeks (Visit 1 to Visit 2)
Side effects are tolerable and transient.
Side effect questionnaire
Measured: 5 weeks (Visit 1 to Visit 2)
The rate of drop-out will be similar in both groups.
Drop-outs will be recorded by the study stuff.
Measured: 5 weeks (Visit 1 to Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start22 Aug 2024
- Primary completion22 Aug 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Parallel groups
- Model description
- Each participant will be randomly assigned to receive either the terpene-enriched CBD oil or a placebo for 5 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bazelet Nehushtan LtD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matitiahu Berkovitch, MD, Principal investigator, Shamir Medical Center, Zerifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542445
- Sponsor's protocol ID
- ASF-0243-22
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Treatment With Cannabidiol (CBD) Oil Enriched With Terpenes, Devoid of THC, in Children Diagnosed With ADHD
- ClinicalTrials.gov ID
- NCT06542445
- Acronym / sponsor ID
- ASF-0243-22
- Keywords
- Cannabidiol, Terpenes, Medical Cannabis, Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bazelet Nehushtan LtD.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 22 Aug 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 7 Aug 2024 (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 neurodevelopmental disorder in childhood. Symptoms often appear in preschool years, and most children (65-80%) continue to experience some ADHD-associated symptoms into adolescence and adulthood. The disorder is marked by age-inappropriate inattention, hyperactivity, and impulsivity. Drug treatments for ADHD include stimulants containing methylphenidate (like Ritalin and Concerta) or amphetamines (like Vyvanse). However, 30-35% of the patients do not respond well to these treatments, and stimulants may result with various side effects.
The use of medical cannabis increases; applied for expending medical conditions, with growing evidence for its beneficial effects. A study on ADHD adults treated by cannabinoids demonstrated improvements in hyperactivity and impulsivity.
The current study is aimed to examine the safety and efficacy of treating children diagnosed with ADHD with a CBD oil (devoid of THC), enriched with terpenes. Participants will be randomly assigned to receive either the enriched CBD oil or a placebo, for 5 weeks (Treatment, Stage I).
At the end of the treatment stage (I), an open-label stage will follow (II), wherein, all participants will receive the investigational product for an additional 5 weeks.
The investigators hypothesize that children treated with the enriched CBD oil (Treatment, Stage I) will show significantly higher improvement in hyperactivity and inattention scores, as compared with the placebo group.
Detailed description
Screening phase:
Parents who are interested to take part in study, will contact the study team. Parents will be asked to provide documents attesting their child's medical status and forms required to process a medical cannabis prescription.
Visit 1 - Baseline:
- Participants and parents will sign an Informed Consent Form.
- Parents will complete questionnaires about the child's health, clinical history, medications, sleep, eating habits, and quality of life.
- Participants will be examined by a pediatrician, who will fill out a physical examination report, including height, weight and blood pressure, and will conduct an urine test.
- Participants will conduct a TOVA (Test of Variables of Attention) test, and answer a CBCL (Child Behavior Checklist) questionnaire.
- Parents and teachers will complete the Conners questionnaires (sent during the screening phase. Conners questionnaires may be filled out prior to Visit 1, but no longer than two weeks prior to Visit 1).
- Participants and parents will receive the study drug/placebo and usage instructions.
Treatment using the study drug (Stage I) will be initiated following Visit 1, according to a schedule set by the study team.
Follow-up 1:
The study team will contact the parents via a phone call two weeks (±2 days) after initiation of stage I. Parents will answer questions regarding general health and side effects.
Visit 2 -at the end of Stage I:
- Five weeks (±3 days) after initiation of stage I.
- Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1.
- All participants will receive new bottles of the investigational product - the CBD oil enriched with terpenes (open label, Stage II).
Follow-up 2:
- The study team will contact the parents via a phone call two weeks (±2 days) after initiation of Stage II. Parents will answer questions regarding general health and side effects.
Visit 3 - at the end of Stage II:
- Five weeks (±3 days) after initiation of stage II.
- Participants and parents will undergo and fill out the same set of examinations and questionnaires as in Visit 1, excluding the TOVA test.
- Study drugs' bottles and cannabis use prescription will be returned to the study team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomly assigned to receive either the terpene-enriched CBD oil or a placebo for 5 weeks.
| Arm | Type | Receives |
|---|---|---|
| CBD oil enriched with terpenes | Active comparator | Drug: Oral CBD oil enriched with terpenes24% CBD, terpenes, MCT oil. |
| Placebo oil | Placebo comparator | Drug: Oral Placebofragrances and flavors, MCT oil. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
- Willing/able to arrive to all the necessary visits as per study protocol.
Key exclusion criteria (26 listed)
- Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
- Participants who used benzodiazepines or first-generation antihistamines in the week before starting the study or other drugs which may interfere with the study as per PI opinion.
- Participants suffering from neurological or psychiatric diseases.
- Participants suffering from neoplastic diseases.
- Participants with syndromes or metabolic diseases.
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 |
|---|---|---|
| Oral CBD oil enriched with terpenesStage I dosing, increasing titration: days 1-2: 2.5 mg/kg BW/day; days 3-4: 5 mg/kg BW/day; day 5-7: 7.5 mg/kg BW/day; days 8-35: 10 mg/kg BW/day. Stage II dosing, increasing titration: days 36-37: 2.5 mg/kg BW/day; days 38-39: 5 mg/kg BW/day; day 40-42: 7.5 mg/kg BW/day; days 43-70:10 mg/kg BW/day. | Drug | CBD oil enriched with terpenes |
| Oral PlaceboOral placebo oil that is similar in appearance and taste to the CBD oil. Titration and dosing identical to those described for the CBD oil. | Drug | Placebo oil |
Primary outcome
Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Conners' Parent Rating Scale
Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Conners' Parent Rating Scale
10 secondary outcomes
Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in TOVA test - Total score, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in inattentiveness sub-score of the Conners' Teacher Questionnaire, as compared with baseline
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in Conners' Teacher Questionnaire - Total score, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Improvement in the scores of CBCL questionnaire, as compared with baseline.
Time frame: 5 weeks (Visit 1 to Visit 2)
Side effects are tolerable and transient.
Time frame: 5 weeks (Visit 1 to Visit 2)
The rate of drop-out will be similar in both groups.
Time frame: 5 weeks (Visit 1 to Visit 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Matitiahu Berkovitch, MD principal investigator
Shamir Medical Center, Zerifin, Israel
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 Oral CBD oil enriched with terpenes in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Bazelet Nehushtan 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 2 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariela Hazan (+972-89778465, arielah@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline. (time frame: 5 weeks (Visit 1 to Visit 2)). 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?
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 23 Aug 2024.