Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 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)
Bazelet Nehushtan LtD.
78 participants
Oct 5, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria8
- 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.
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Interventions
Oral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD/THC: 280/10 mg per g) produced by Bazelet Group, Israel.
Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.
Oral cannabidiol (CBD; 7.2 mg/kg/day) and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07199218