Terpenes‑enriched CBD oil with a very small THC dose for children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, placebo‑controlled study will enroll 78 children ages 4–12 with confirmed autism and moderate or greater symptom severity. Participants are randomized to daily terpene‑enriched CBD oil (28% CBD, 1% THC) or matching placebo for 8 weeks, after which all participants receive an active CBD oil without THC for an additional 8 weeks. Outcomes include standardized measures of behavior, social responsiveness, and quality of life, with safety monitored by clinic visits, physical exams, questionnaires, and blood tests every two months. The design allows comparison of short‑term efficacy versus placebo and assessment of safety and tolerability during the open‑label phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 4 to 12 years (after the 4th birthday and before the 13th).
2. Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
3. 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).
4. Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
5. Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.

Exclusion Criteria:

1. Body weight \<12.5 kg or ≥57.5 kg.
2. 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.
3. Seizure or change in antiepileptic medications within 4 months prior to randomization.
4. Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
5. 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.
6. Cannabinoid treatment within 4 weeks prior to randomization.
7. Predicted poor compliance with study procedures (e.g., blood tests).
8. Concurrent use of opiates or alcohol.

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, N/A = Not Applicable, Israel Recruiting

Study contacts

• Study coordinator: Adi Aran, MD
• Email: aaran@szmc.org.il
• Phone: +97226555414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.