A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder

Summary

This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.

Timeline

Start

2020-09-01

Primary completion

2022-09-01

Completion

2022-09-01

Outcome

Outcome not reported

Stopped: “withdrawn due to COVID-19”

Drugs

Indications