NCT06542445 The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
| NCT ID | NCT06542445 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bazelet Nehushtan LtD. |
| Condition | Attention Deficit Hyperactivity Disorder (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-22 |
| Primary Completion | 2026-08-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-08-22 with a primary completion date of 2026-08-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Matitiahu Berkovitch, MD
PRINCIPAL INVESTIGATOR
Shamir Medical Center, Zerifin, Israel
Frequently Asked Questions
Who can join the NCT06542445 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Attention Deficit Hyperactivity Disorder (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06542445 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06542445 currently recruiting?
Yes, NCT06542445 is actively recruiting participants. Contact the research team at arielah@shamir.gov.il for enrollment information.
Where is the NCT06542445 trial being conducted?
This trial is being conducted at Ẕerifin, Israel.
Who is sponsoring the NCT06542445 clinical trial?
NCT06542445 is sponsored by Bazelet Nehushtan LtD.. The principal investigator is Matitiahu Berkovitch, MD at Shamir Medical Center, Zerifin, Israel. The trial plans to enroll 120 participants.