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

NCT06542445 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-23

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

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.

Sponsors & Collaborators

  • Bazelet Nehushtan LtD.

    lead INDUSTRY

Principal Investigators

  • Matitiahu Berkovitch, MD · Shamir Medical Center, Zerifin, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2026-08-22
Completion
2026-09-22

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542445 on ClinicalTrials.gov