Cannabinoids for Behavioral Problems in Children With ASD

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Dronabinol

Criteria

Inclusion Criteria: (both are needed)

• ASD diagnosis (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition; DSM-V]

• Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)

Exclusion Criteria:

• Planned changes in existing interventions for the duration of the trial or such a change in the last 4 weeks.

• Current treatment with cannabis based therapy or such a treatment in the last 3 months.

• Heart, liver, renal or hematological disorders

• History of psychotic disorder in a first degree relative.