Terpenes‑enriched CBD oil with a very small THC dose for children with autism
A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study to Assess the Safety, Tolerability and Efficacy of Terpenes-enriched Cannabis Oil T1/C28, Administered to Pediatric Subjects With Autism Spectrum Disorder (ASD)
This trial will test whether a terpene‑enriched CBD oil with a very small amount of THC can reduce behavioral problems and improve social functioning in children ages 4–12 with autism.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 4 Years to 13 Years |
| Sex | All |
| Sponsor | Bazelet Nehushtan LtD. Industry-sponsored |
| Locations | 1 site (Jerusalem, N/A = Not Applicable) |
| Trial ID | NCT07199218 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children ages 4–12 with a DSM‑5 diagnosis of autism confirmed by CARS‑2, moderate or greater symptom severity (CGI‑S ≥4), ABC‑I score ≥18, SRS‑2 T score ≥66, and within the study weight range who do not have excluded medical or psychiatric conditions are ideal candidates.
Not a fit: Children with recent seizure activity or changes in antiepileptic drugs, major psychiatric disorders (for example schizophrenia, bipolar disorder, PTSD, or major depressive disorder), those outside the allowed weight range, or who cannot attend required clinic visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, this treatment could reduce irritability and social difficulties in some children with autism while offering an alternative side‑effect profile to commonly used antipsychotics.
How similar studies have performed: Small open‑label reports and limited randomized studies of CBD or CBD/THC combinations in autism have shown mixed but sometimes promising findings, so high‑quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jerusalem, N/A = Not Applicable
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.