From: Cannabinoid treatment for autism: a proof-of-concept randomized trial
Inclusion criteria | 1. Male or female outpatients aged 5–21 years olda 2. Diagnosis of ASD according to Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition; DSM-5] 3. Moderate or greater behavioral problems as measured by a Clinical Global Impression Scale—Severity (CGI-S) score of 4 or higher at screeningb 4. Involvement of a parent or caregiver able to consistently complete assessments throughout the study |
Exclusion criteria | 1. Lifetime history of psychotic disorder 2. Current or former treatment with cannabinoids 3. A medical condition (such as heart, liver, renal or hematological disorder) that impacts the subject's ability to participate in the study or makes the subject predisposed to severe adverse events 4. Subjects who have had changes in pharmacological, educational, or behavioral treatments for 4Â weeks prior to randomization or planned changes in existing interventions for the duration of the trial |