NCT06542445

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Bazelet Nehushtan LtD. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	Oral 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.
DRUG	Oral 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.

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-08-22
• Completion: 2026-09-22
• First posted: 2024-08-07
• Last updated: 2024-08-23

Locations

1 site across 1 country: Israel