Clinical Trial: Plant-Derived Cannabis Preparation Is Safe and Effective in Children with Autism
- The twice-daily administration of a standardized cannabis extract (NTI164) is safe and leads to significant clinical improvements in children and adolescents with moderate to severe autism spectrum disorder (ASD), according to a placebo-controlled trial.
- The study involved 54 participants over eight weeks, showing that those receiving NTI164 experienced reductions in disease severity and improvements in anxiety, emotional regulation, social responsiveness, communication, and cognition.
- Adverse events were mild, non-serious, and resolved on their own, with caregivers also reporting enhanced family experiences and quality of life following treatment.
- The findings support growing evidence for cannabinoids’ therapeutic role in ASD and neurodevelopmental disorders, encouraging further clinical development of standardized cannabis extracts like NTI164.
The twice daily administration of a standardized cannabis extract is safe and provides clinically meaningful improvements in children and adolescents with autism spectrum disorder (ASD), according to placebo-controlled clinical trial data published in the journal Neurotherapeutics.
Australian researchers assessed a proprietary cannabis extract (aka NTI164) versus a placebo in 54 young people diagnosed with moderate to severe ASD. Extracts possessed standardized percentages of CBD, CBDV (cannabidivarian), THC, and other plant-derived cannabinoids. Study participants consumed either the extract or the placebo twice daily for eight weeks. Following the conclusion of the initial study period, patients who received the placebo had the option of switching to the extract.
Patients consuming NTI164 experienced significant improvements compared to controls. Specifically, patients’ disease severity fell an estimated 2 points on a 7-point scale following eight weeks of cannabinoid treatment. Those receiving the extract also showed demonstrable improvements in anxiety, emotional regulation, social awareness and responsiveness, communication skills, and cognition. Participants who later transitioned to the extract in the open label phase of the trial reported similar benefits.
Adverse events associated with the extract were classified as “mild,” “non-serious,” and “self-resolving.”
“NTI164 demonstrated an excellent safety profile and statistically significant and meaningful improvements compared to placebo in overall clinical severity, adaptive functioning, social responsiveness, and affective symptoms,” the study’s authors summarized. “Caregivers also reported improved family experiences and quality of life” following treatment.
They concluded: “The findings of [this] study are consistent with a growing body of evidence supporting the therapeutic role of cannabinoids in ASD and other neurodevelopmental disorders. … [The] consistent benefits reported by both clinicians and caregivers in both open label and double-blind contexts support further clinical development of [this standardized cannabis extract] in ASD.”
Observational studies and clinical trials from Brazil, Israel the United Kingdom, and elsewhere have similarly reported improvement in ASD symptoms in both young people and adults who consume various cannabis preparations, including oil extracts and flower.
The full text of the study, “NTI164, a novel medicinal cannabis extract, improves core symptoms of autism spectrum disorder: Results from a double-blind, randomized, controlled trial (The Harmony Study),” appears online in Neurotherapeutics.”
Additional information on cannabinoids and ASD is available from NORML’s publication, Clinical Applications for Cannabis and Cannabinoids.