Cannabinoids for Behavioral Problems in Children With ASD

Phase 2 Completed 150 enrolled Shaare Zedek Medical Center

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study aims to assess the safety, tolerability and efficacy of cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel\] for behavioral problems in children and youth with ASD.

Timeline

Start: 2017-01
Primary completion: 2018-10
Completion: 2018-12

Outcome

Mixed primary results

paper Changes in Total Scores of HSQ-ASD (primary-outcome) and APSI (secondary-outcome) did not differ among groups. PMID 33536055 ↗

paper Disruptive behavior on the CGI-I (co-primary outcome) was either much or very much improved in 49% on whole-plant extract (n = 45) versus 21% on placebo (n = 47; p = 0.005). PMID 33536055 ↗

Publications

Aran A, Harel M, Cassuto H, Polyansky L, Schnapp A, Wattad N, Shmueli D, Golan D, Castellanos FX. Cannabinoid treatment for autism: a proof-of-concept randomized trial. Mol Autism. 2021 Feb 3;12(1):6. doi: 10.1186/s13229-021-00420-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BOL-DP-O-01	Unknown	10 mg/kg	Oral
Subject	BOL-DP-O-01-W	Unknown	10 mg/kg	Oral