Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Autism, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT07199218

Run by

Bazelet Nehushtan LtD.

People needed

78

Starts

2025-10-05

Expected to finish

2028-03-03

Last updated by the study team

2025-11-19

Who can join

Age: 4 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 4 to 12 years (after the 4th birthday and before the 13th).
• Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
• Moderate or greater ASD-associated symptoms, defined as a rating of ≥4 ("moderate" or higher) on the Overall Function Clinical Global Impression-Severity (CGI-S).
• Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
• Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.

You may not qualify if…

• Body weight <12.5 kg or ≥57.5 kg.
• Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder (PTSD), or major depressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.
• Seizure or change in antiepileptic medications within 4 months prior to randomization.
• Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
• Change in pharmacological or behavioral treatment, or change in home or school environment (other than school holidays), within 4 weeks prior to randomization or planned during the study.
• Cannabinoid treatment within 4 weeks prior to randomization.
• Predicted poor compliance with study procedures (e.g., blood tests).
• Concurrent use of opiates or alcohol.

Where it is running

• Shaare Zedek Medical Center — Jerusalem, N/A = Not Applicable, Israel (enrolling)

Full record on ClinicalTrials.gov

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