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

NCT07199218 | Recruiting Phase 2 DMC

• 2 other identifiers: 0336-24-SZMCMOH_2025-04-21_014042
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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. 1.Does this treatment improve behavioral challenges in children with autism?
2. 2.Does this treatment improve social difficulties in children with autism?
3. 3.Participants take either the study treatment or a placebo (a look-alike substance with no active drug) every day for 2 months.
4. 4.After 2 months, all participants receive the study treatment or a similar treatment without THC for another 2 months.
5. 5.Participants come to the clinic once every 2 months for checkups and tests.

Conditions

Autism; Autism Spectrum Disorder

Keywords

autism; ASD; cannabidiol; terpenes; THC

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)

  The ABC-C is a caregiver-completed questionnaire with 58 items, divided into five subscales. The ABC-I (Irritability) subscale includes 15 items that assess emotional and behavioral symptoms of ASD, such as aggression toward others, deliberate self-injury, temper tantrums, depressed mood, and rapidly shifting moods. Scores on this subscale range from 0 to 45, with higher scores indicating greater severity. Change from baseline to Week 8 is reported, with lower scores reflecting clinical improvement.

  Baseline to Week 8

Secondary Outcomes (7)

• Change From Baseline in Vineland™-III Adaptive Behavior Scales (VABS3) Socialization Domain Standard Score

  Baseline to Week 8

• Change From Baseline in Social Responsiveness Scale-2nd edition (SRS-II) total raw score

  Baseline, Weeks 8 and 17

• Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)

  Baseline to Week 17

• Number of Participants With Clinically Significant Abnormal Laboratory Values

  Week 8

• Change From Baseline in Body Mass Index (BMI)

  Baseline, Weeks 8 and 17

Other Outcomes (10)

• Change From Baseline in Aberrant Behavior Checklist-Community (ABC-C): Irritability Subscale raw score (ABC-I)

  Baseline, Week 17

• Change From Baseline in Vineland™ Adaptive Behavior Scales (VABS-3) Communication Domain Score

  Baseline to Week 8

• Change From Baseline in Vineland™ Adaptive Behavior Scales (VABS-3) Maladaptive Behavior Domain Score

  Baseline to Week 8

Study Arms (2)

Terpenes-Enriched CBD-Predominant Oil

EXPERIMENTAL

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.

Drug: Terpenes-Enriched CBD-Predominant Oil

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Terpenes-Enriched CBD Oil (THC-Free)

Interventions

Terpenes-Enriched CBD-Predominant Oil 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.

Terpenes-Enriched CBD-Predominant Oil

Placebo DRUG

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

Placebo

Terpenes-Enriched CBD Oil (THC-Free) 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.

Placebo

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bazelet Nehushtan LtD.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, N/A = Not Applicable, 9640610, Israel

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Adi Aran, MD

CONTACT

+97226555414; aaran@szmc.org.il

Daniel Korenfine

CONTACT

danielko@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuropediatric unit, SZMC

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 30, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 3, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study protocol, statistical analysis plan (SAP), and informed consent form (ICF) are available prior to enrollment of the first participant. De-identified individual participant data and the clinical study report (CSR) are available beginning 12 months after publication of the primary results and remain available for up to 5 years.
• Access Criteria: The study protocol, statistical analysis plan (SAP), and informed consent form (ICF) are available to the public prior to enrollment of the first participant. De-identified individual participant data (baseline characteristics, outcome measures, and safety data) and the clinical study report (CSR) are available to qualified researchers beginning 12 months after publication of the primary results. Access requires submission of a methodologically sound proposal, approval by the principal investigator and ethics committee, and execution of a data use agreement.

Locations

IL (1)