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Status unknownNCT06542445Updated Aug 23, 2024

The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD

A Phase 2 interventional study of Oral CBD oil enriched with terpenes and Oral Placebo in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Bazelet Nehushtan LtD.. Status unknown at 1 site in Israel. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Bazelet Nehushtan LtD. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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. 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.

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.
02

Conditions studied

  • Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

  • Cannabidiol
  • Terpenes
  • Medical Cannabis
  • Attention Deficit Hyperactivity Disorder
03

In context

Attention Deficit Disorder with Hyperactivity

1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's planned enrollment of 120 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Bazelet Nehushtan LtD. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.
  2. Willing/able to arrive to all the necessary visits as per study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Participants who used ADHD conventional medications in the month before starting the study or intend to do so during the study.
  2. 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.
  3. Participants suffering from neurological or psychiatric diseases.
  4. Participants suffering from neoplastic diseases.
  5. Participants with syndromes or metabolic diseases.
  6. Participants with a significant clinic diagnosis which may interfere with the study. May be included later on as per PI opinion.
  7. Pregnant or breastfeeding adolescents.
  8. Sexually active female adolescents who are unwilling to use contraceptives.
  9. 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.)
  10. Participants with less than 18 kg or more than 90 kg weight.
  11. Participants with BMI lower than 18 or higher than 29.9.
  12. Participants engaged in another clinical study which includes a medicine.
  13. Participants engaged in another study regarding ADHD treatment of any kind.
  14. Participants using alcohol or drugs.
  15. Past or present use of Cannabis, including medical cannabis

Criteria for early termination:

  1. Use of another medication for ADHD during the study.
  2. Use of a medication from the exclusion criteria list during the study.
  3. Use of alcohol or drugs during the study.
  4. Participants who got pregnant during the study.
  5. Participants who split the first visit and did not arrive to the second part of the first visit after a maximum of 28 days.
  6. Participants who did not start the treatment during the 14 days from receiving the drug.
  7. Non -compliant participants.

Criteria for exchange:

  1. PI may exchange participants that quit, if they did not start treatment for new participants.
  2. PI may recruit again participants who quit after a new full recruitment process.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    CBD oil enriched with terpenes

    24% CBD, terpenes, MCT oil.

    Drug: Oral CBD oil enriched with terpenes

  • Placebo comparator
    Placebo oil

    fragrances and flavors, MCT oil.

    Drug: Oral Placebo

Interventions

  • DrugOral CBD oil enriched with terpenes

    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.

  • DrugOral Placebo

    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.

06

What researchers measure

Primary outcomes

  1. Improvement in hyperactivity sub-score of the Conners' Parent Questionnaire, as compared with baseline.

    Conners' Parent Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

  2. Improvement in inattentiveness sub-score of the Conners' Parent Questionnaire, as compared with baseline.

    Conners' Parent Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

Secondary outcomes

  1. Improvement in Conners' Parent Questionnaire - Total score, as compared with baseline.

    Conners' Parent Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

  2. Improvement in hyperactivity sub-score of the TOVA test, as compared with baseline.

    Computerized visual T.O.V.A

    Time frame: 5 weeks (Visit 1 to Visit 2)

  3. Improvement in inattentiveness sub-score of the TOVA test, as compared with baseline.

    Computerized visual T.O.V.A

    Time frame: 5 weeks (Visit 1 to Visit 2)

  4. Improvement in TOVA test - Total score, as compared with baseline.

    Computerized visual T.O.V.A

    Time frame: 5 weeks (Visit 1 to Visit 2)

  5. Improvement in hyperactivity sub-score of the Conners' Teacher Questionnaire, as compared with baseline.

    Conners' Teacher Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

  6. Improvement in inattentiveness sub-score of the Conners' Teacher Questionnaire, as compared with baseline

    Conners' Teacher Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

  7. Improvement in Conners' Teacher Questionnaire - Total score, as compared with baseline.

    Conners' Teacher Rating Scale

    Time frame: 5 weeks (Visit 1 to Visit 2)

  8. Improvement in the scores of CBCL questionnaire, as compared with baseline.

    Child Behavior Checklist (CBCL)

    Time frame: 5 weeks (Visit 1 to Visit 2)

  9. Side effects are tolerable and transient.

    Side effect questionnaire

    Time frame: 5 weeks (Visit 1 to Visit 2)

  10. The rate of drop-out will be similar in both groups.

    Drop-outs will be recorded by the study stuff.

    Time frame: 5 weeks (Visit 1 to Visit 2)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Aug 2026, 24 months after the start.

Of 24 industry-sponsored phase 2 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 24 months is above that.

Counting every sponsor, half of 39 studies reached it within 14 months; a quarter within 5 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2024
First posted
Aug 7, 2024
StartActual
Aug 22, 2024
Primary completionEst.
Aug 22, 2026
CompletionEst.
Sep 22, 2026
Last update
Aug 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06542445
Lead sponsor
Bazelet Nehushtan LtD.
Responsible party
Sponsor
First posted
Aug 7, 2024
Start date
Aug 22, 2024
Primary completion
Aug 22, 2026 (estimated)
Completion
Sep 22, 2026 (estimated)
Last update
Aug 23, 2024

Study contacts

Ariela Hazan
Contact
arielah@shamir.gov.il
+972-89778465
Elkana Kohn, PhD
Contact
elkanak@shamir.gov.il
+972-89542181
Matitiahu Berkovitch, MD
principal investigator · Shamir Medical Center, Zerifin, Israel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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