Actively Recruiting
The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
Led by Bazelet Nehushtan LtD. · Updated on 2024-08-23
120
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Safety and Efficacy of Terpene-enriched Cannabidiol (CBD) Oil in ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children or adolescents aged 6 to 18 years diagnosed with ADHD according to DSM-V by a neurologist, psychiatrist, or other specialist
- Willing and able to attend all required study visits as per protocol
You will not qualify if you...
- Use of ADHD medications within one month prior to the study or intention to use them during the study
- Use of benzodiazepines, first-generation antihistamines, or other interfering drugs within one week prior to the study
- Presence of neurological or psychiatric diseases
- Diagnosis of neoplastic diseases
- Syndromes or metabolic diseases
- Significant clinical diagnoses that may interfere with the study (may be reconsidered by principal investigator)
- Pregnant or breastfeeding adolescents
- Sexually active female adolescents unwilling to use contraceptives
- Non-compliance with study protocol such as not using contraceptives
- Weight less than 18 kg or more than 90 kg
- Body mass index (BMI) below 18 or above 29.9
- Participation in another clinical study involving medication
- Participation in other ADHD treatment studies
- Use of alcohol or drugs
- Past or current use of cannabis, including medical cannabis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shamir Medical Center
Ẕerifin, Israel
Actively Recruiting
Research Team
A
Ariela Hazan
CONTACT
E
Elkana Kohn, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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