Clinical Trial Confirms Safety of Cannabis Extract For Autistic Youth

Study Design and Participants

Australian researchers published new data in the journal Neurotherapeutics regarding a standardized cannabis extract called NTI164. The study focused on children and adolescents diagnosed with moderate to severe autism spectrum disorder.

Participants consumed either the extract or a placebo twice daily for eight weeks. The extract possessed standardized percentages of CBD, CBDV, THC, and other plant-derived cannabinoids. This design allowed for a direct comparison between the active treatment and the control group.

Following the initial study period, patients who received the placebo had the option to switch to the extract. This open-label phase allowed researchers to observe long-term effects in those who initially received the control substance. The trial structure ensured a rigorous assessment of the product’s impact.

Measured Clinical Improvements

Patients consuming NTI164 experienced significant improvements compared to those in the control group. Specifically, the study found that patients’ disease severity fell an estimated 2 points on a 7-point scale following eight weeks of treatment. This reduction indicates a meaningful change in the overall condition of the participants.

Those receiving the extract also showed demonstrable improvements in anxiety and emotional regulation. Additionally, participants demonstrated better communication skills and cognition during the trial period.

Participants who later transitioned to the extract in the open-label phase reported similar benefits. These results suggest that the therapeutic effects were consistent across different phases of the study. The findings align with the goal of improving core symptoms in autistic youth.

Safety Profile and Future Steps

Adverse events associated with the extract were classified as “mild,” “non-serious,” and “self-resolving.” The study’s authors summarized that “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.” This statement underscores the favorable risk-benefit ratio observed in the trial.

Caregivers also reported improved family experiences and quality of life following the treatment. The authors concluded that consistent benefits reported by both clinicians and caregivers support further clinical development of the standardized cannabis extract in ASD. The full text of the study appears in Neurotherapeutics.

The findings are consistent with a growing body of evidence supporting the therapeutic role of cannabinoids in ASD and other neurodevelopmental disorders. The study authors stated that these results support further clinical development of the extract. This marks a significant step in the clinical application of cannabis for this population.

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