Evaluating the effects of terpene-enriched CBD oil on ADHD in children

The Safety and Efficacy of Treatment With Cannabidiol (CBD) Oil Enriched With Terpenes, Devoid of THC, in Children Diagnosed With ADHD

This study is testing if a special CBD oil can help children with ADHD feel better and manage their symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: Bazelet Nehushtan LtD. (Industry-sponsored)
• Locations: 1 site (Ẕerifin)
• Trial ID: NCT06542445 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a terpene-enriched cannabidiol (CBD) oil in treating children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). The study involves a screening phase where parents provide documentation of their child's medical status, followed by a baseline visit that includes health assessments and questionnaires. Participants will be randomly assigned to receive either the CBD oil or a placebo, with follow-up assessments to monitor health and side effects over a five-week treatment period.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6-18 diagnosed with ADHD according to DSM-V criteria.

Not a fit: Patients currently using conventional ADHD medications or those with significant neurological or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an alternative option for children with ADHD who do not respond well to conventional medications.

How similar studies have performed: Previous studies have shown improvements in ADHD symptoms with cannabinoid treatments, suggesting potential for success with this approach.

Eligibility criteria

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:

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.

Where this trial is running

Ẕerifin

• Shamir Medical Center — Ẕerifin, Israel (Recruiting)

Study contacts

• Principal investigator: Matitiahu Berkovitch, MD — Shamir Medical Center, Zerifin, Israel
• Study coordinator: Ariela Hazan

Conditions Attention Deficit Hyperactivity Disorder; Cannabidiol; Terpenes; Medical Cannabis