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

NCT07199218 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-11-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

DRUG

Placebo

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

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.

Sponsors & Collaborators

  • Bazelet Nehushtan LtD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-05
Primary Completion
2027-12-31
Completion
2028-03-03

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199218 on ClinicalTrials.gov