Cannabis Oil Study for Children With Autism
Tests a cannabis oil with a placebo in children aged 4 to 13 with autism.
Plain-language title generated from the registry record
Registry title: Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism
Key facts
- Where
- Jerusalem, IsraelSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 13 years old?
Source: NCT07199218, who can take part
Where in Israel
- Shaare Zedek Medical CenterJerusalem, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bazelet Nehushtan LtD.
- Trial code
- NCT07199218
- Record updated
- 19 November 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Seizure or change in antiepileptic medications within 4 months prior to randomization; 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; Concurrent use of opiates or alcohol; 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; Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function; Body weight <12.5 kg or ≥57.5 kg; Predicted poor compliance with study procedures (e.g., blood tests).