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

NCT ID: NCT07199218

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-05
• Study Completion Date: 2028-03-03

Brief 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.

Detailed 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.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Terpenes-Enriched CBD-Predominant Oil

Oral cannabidiol (CBD), tetrahydrocannabinol (THC; 1/28 of the CBD dose), and terpenes, administered for 8 weeks as an add-on to existing treatments. After the first 8 weeks, participants will continue with the same treatment for an additional 8 weeks.

Group Type: EXPERIMENTAL

Terpenes-Enriched CBD-Predominant Oil

Intervention Type: DRUG

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.

Placebo

Oral olive oil with flavoring to mimic the texture and taste of the study drug, given for 8 weeks. After the first 8 weeks, participants will switch to terpenes-enriched CBD oil without THC for another 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.

Terpenes-Enriched CBD Oil (THC-Free)

Intervention Type: DRUG

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.

Interventions

Terpenes-Enriched CBD-Predominant Oil

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.

Intervention Type: DRUG

Placebo

Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.

Intervention Type: DRUG

Terpenes-Enriched CBD Oil (THC-Free)

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bazelet Nehushtan LtD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Adi Aran

Director, Neuropediatric unit, SZMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shaare Zedek Medical Center

Jerusalem, N/A = Not Applicable, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Adi Aran, MD

Role: CONTACT

aaran@szmc.org.il

+97226555414

Daniel Korenfine

Role: CONTACT

danielko@szmc.org.il

Facility Contacts

Adi Aran, MD

Role: primary

aaran@szmc.org.il

0508685034

Daniel Korenfine

Role: backup

danielko@szmc.co.il

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Study Protocol

Study protocol, statistical analysis plan, and parental informed consent form are available in the OSF repository: https://osf.io/f69ds/files/osfstorage (Updated September 2025)

View Document

Document Type: Statistical Analysis Plan

Study protocol, statistical analysis plan, and parental informed consent form are available in the OSF repository: https://osf.io/f69ds/files/osfstorage (Updated September 2025)

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MOH_2025-04-21_014042

Identifier Type: REGISTRY

Identifier Source: secondary_id

0336-24-SZMC

Identifier Type: -

Identifier Source: org_study_id