Actively Recruiting
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
Led by Bazelet Nehushtan LtD. · Updated on 2025-11-19
78
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine whether cannabidiol (CBD, 28%) combined with terpenes and a small amount of THC (1%) can help reduce symptoms of autism, and to evaluate the safety of this treatment. The main questions are: 1. Does this treatment improve behavioral challenges in children with autism? 2. Does this treatment improve social difficulties in children with autism? What will happen in the study: 1. Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months. 2. After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months. 3. Participants come to the clinic once every 2 months for checkups and tests.
CONDITIONS
Official Title
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 12 years (after the 4th birthday and before the 13th)
- Diagnosis of autism spectrum disorder (ASD) confirmed by DSM-5 and Childhood Autism Rating Scale-Second Edition (CARS-2)
- Moderate or greater ASD symptoms with Overall Function Clinical Global Impression-Severity (CGI-S) rating of 4 or higher
- Aberrant Behavior Checklist-Irritability subscale (ABC-I) score of 18 or more
- Social Responsiveness Scale-Second Edition (SRS-2) total T score of 66 or more
You will not qualify if you...
- Body weight less than 12.5 kg or greater than 57.5 kg
- Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, PTSD, major depressive disorder, or schizophrenia in a first-degree relative
- Seizure or change in antiepileptic medications within 4 months before randomization
- Significant abnormalities in physical exam or lab tests, including heart, liver, or kidney problems
- Change in medication, behavioral treatment, or home/school environment within 4 weeks before randomization or planned during the study
- Cannabinoid treatment within 4 weeks before randomization
- Expected poor compliance with study procedures
- Current use of opiates or alcohol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shaare Zedek Medical Center
Jerusalem, N/A = Not Applicable, Israel, 9640610
Actively Recruiting
Research Team
A
Adi Aran, MD
CONTACT
D
Daniel Korenfine
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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