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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Children/adolescents aged 6-18 diagnosed with ADHD as per DSM-V by a neurologist, psychiatrist or other specialist.

• Willing/able to arrive to all the necessary visits as per study protocol.

Locations
Other Locations
Israel
Shamir Medical Center
RECRUITING
Ẕerifin
Contact Information
Primary
Ariela Hazan
arielah@shamir.gov.il
+972-89778465
Backup
Elkana Kohn, PhD
elkanak@shamir.gov.il
+972-89542181
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2026-09-22
Participants
Target number of participants: 120
Treatments
Active_comparator: CBD oil enriched with terpenes
24% CBD, terpenes, MCT oil.
Placebo_comparator: Placebo oil
fragrances and flavors, MCT oil.
Sponsors
Leads: Bazelet Nehushtan LtD.

This content was sourced from clinicaltrials.gov