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

Last updated: November 15, 2025
Sponsor: Bazelet Nehushtan LtD.
Overall Status: Active - Recruiting

Phase

2

Condition

Asperger's Disorder

Williams Syndrome

Autism

Treatment

Terpenes-Enriched CBD-Predominant Oil

Terpenes-Enriched CBD Oil (THC-Free)

Placebo

Clinical Study ID

NCT07199218
0336-24-SZMC
MOH_2025-04-21_014042
  • Ages 4-13
  • All Genders

Study 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 Criteria

Inclusion

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 byChildhood 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

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 majordepressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.

  3. Seizure or change in antiepileptic medications within 4 months prior torandomization.

  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 schoolenvironment (other than school holidays), within 4 weeks prior to randomization orplanned 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.

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: Terpenes-Enriched CBD-Predominant Oil
Phase: 2
Study Start date:
October 05, 2025
Estimated Completion Date:
March 03, 2028

Study Description

Autism spectrum disorder (ASD) is a condition that affects communication, social interaction, and behavior. Current medications do not treat the core symptoms of autism, and the drugs sometimes prescribed (such as antipsychotics for irritability) can cause significant side effects.

Cannabidiol (CBD) is a natural, non-psychoactive compound from the cannabis plant that may reduce brain overactivity and inflammation. Tetrahydrocannabinol (THC), the psychoactive component of cannabis, acts on the endocannabinoid system, which is thought to function differently in people with autism. Research suggests that CBD combined with very small amounts of THC may improve behavior and social functioning. Other plant compounds called terpenes may enhance the effects of CBD and THC, even at low doses.

This study tests whether a CBD oil enriched with terpenes and a very small amount of THC is safe and effective for children with autism. Seventy-eight children, ages 4-13, will participate. Half will receive the study oil and half will receive a placebo (an inactive oil that looks the same) for 8 weeks. Afterward, all participants will receive an active treatment for another 8 weeks.

The study evaluates whether the treatment improves behavior, social skills, and quality of life. Safety is monitored through regular clinic visits, questionnaires, physical exams, and blood tests.

Connect with a study center

  • Shaare Zedek Medical Center

    Jerusalem 281184, N/A = Not Applicable 9640610
    Israel

    Active - Recruiting

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