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

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.

NCT Number	NCT07199218
Lead Sponsor	Bazelet Nehushtan LtD.
Conditions	Autism, Autism Spectrum Disorder
Enrollment	78 participants
Start Date	2025-10-05
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-03-03 (estimated)
Updated on ClinicalTrials.gov	2025-11-19