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

Launched by BAZELET NEHUSHTAN LTD. · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special type of CBD oil, which is enriched with terpenes, for treating children with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common condition that causes problems with paying attention, being overly active, and acting impulsively. While there are traditional medications available, not all children respond well to them. This trial aims to see if the terpene-enriched CBD oil can help improve symptoms in children aged 6 to 18 who have been diagnosed with ADHD.

If eligible, participants will be randomly assigned to receive either the CBD oil or a placebo (an inactive treatment) for five weeks. After this initial phase, everyone will receive the CBD oil for another five weeks. To participate, children must have a confirmed ADHD diagnosis, not be on other ADHD medications, and be able to attend all study visits. This study is an opportunity for families looking for new treatment options for ADHD, but it's important to know that certain health conditions and medications may exclude some children from participating.

Gender

ALL

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.