# Harmony Trial: What the NTI164 Autism Study Actually Reported > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/low-thc-full-spectrum-cannabis-extract-autism-trial/ > **Published:** 2026-08-31T12:36:25-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:46:20-04:00 > **Clinical Summary:** The Harmony trial of NTI164 in autism improved overall clinical severity, but its social responsiveness total missed significance at p=0.055. What it reported. --- ✦ New CED Clinical Relevance #67 Notable Clinical Interest Emerging findings or policy developments worth monitoring closely. [Mental Health](https://cedclinic.com/cannabis-psychiatric-research-findings-depression-anxiety/)PediatricsNeurologyResearchCBDTHCSafety Why This Matters This randomized [clinical trial](https://cedclinic.com/weekly-medical-cannabis-research-radar-2026-09-04/) matters for clinicians and their patients as it provides evidence on the effectiveness of low-THC full-spectrum cannabis extract in managing symptoms of moderate-to-severe autism spectrum disorder (ASD) in children aged 8 to 17. The findings could potentially expand treatment options for this patient population, contributing to improved [clinical practice](https://cedclinic.com/cannabis-reproductive-health-women-clinical-evidence/) and [patient care](https://cedclinic.com/cannabis-cardiovascular-risk-impact/). Clinical Summary In the Harmony trial, 61 children and adolescents aged 8 to 17 with Level II or III autism spectrum disorder were randomized to NTI164, a full-spectrum extract containing less than 0.3% THC, or placebo for 8 weeks, and 54 were analyzed. The prespecified primary endpoint was clinician-rated overall severity on the CGI-S, which improved relative to placebo. On the caregiver-rated Social Responsiveness Scale, the total T-score did not reach statistical significance (least squares mean difference -2.71, p = 0.055); two of its five subscales separated. The largest effects in the trial were on anxiety and mood, which are associated rather than core symptoms. The trial applied no adjustment for multiplicity to secondary outcomes. Dr. Caplan’s Take This is a small industry-funded trial with one positive primary endpoint, and it deserves to be read at that size. The paper is titled as improving core symptoms, but its own results section reports the social responsiveness total as not statistically significant. The effects that reached significance most clearly were on anxiety and mood. That is a meaningful finding for families, and it is a different claim from changing the core features of autism. Replication by an independent group, with a multiplicity-adjusted analysis, is the next thing to wait for. Clinical Perspective 🔬 A randomized placebo-controlled trial in children and adolescents with moderate-to-severe autism spectrum disorder reported improvement on its primary measure of overall clinical severity, with the clearest secondary effects on anxiety and mood rather than on core social communication measures. However, it’s crucial to acknowledge the complexity of this finding, as confounders such as individual response variability, concurrent medication use, and long-term effects remain to be fully explored. In [clinical practice](https://cedclinic.com/cannabis-reproductive-health-women-clinical-evidence/), healthcare providers may consider discussing the potential benefits and risks associated with [cannabis therapy](https://cedclinic.com/cannabis-based-therapies-smoking-cessation/) in managing symptoms of ASD, while emphasizing the need for ongoing monitoring and adjustment of treatment plans based on individual patient responses. 💬 Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan →](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? [Join the forum discussion →](https://cedclinic.com/interact/discussion-forums/forum/mental-health/) Have thoughts on this? Share it: [X Share on X](https://twitter.com/intent/tweet?text=Just%20read%20this%20on%20CEDclinic.com%3A%20Randomized%20Clinical%20Trial%20Finds%20Low-THC%20Full-Spectrum%20Cannabis%20Extract%20Significantly%20...%20%40drcaplan&url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D75290)[in Share on LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D75290)[🦅 Share on BlueSky](https://bsky.app/intent/compose?text=Just%20read%20this%3A%20Randomized%20Clinical%20Trial%20Finds%20Low-THC%20Full-Spectrum%20Cannabis%20Extract%20Significantly%20...%20via%20%40drcaplan.bsky.social%20https%3A%2F%2Fcedclinic.com%2F%3Fp%3D75290)[📷 Follow on Instagram](https://www.instagram.com/drbenjamincaplan)[📝 Read more on Substack](https://doctorapprovedcannabis.substack.com/)[🔔 Subscribe via RSS](https://cedclinic.com/feed/) Related Articles - [Study Finds CBD Improves Social Deficits, Hyperactivity and Repetitive Behaviors in Autism Model](https://cedclinic.com/study-finds-cbd-improves-social-deficits-hyperactivity-and-repetitive-behaviors-in-autism-model/) - [Can THC Quiet PTSD Nightmares? New Research Offers Clues](https://cedclinic.com/can-thc-quiet-ptsd-nightmares-new-research-offers-clues/) - [Clinical Trial: Plant-Derived Cannabis Preparation Is Safe and Effective in Children with Autism](https://cedclinic.com/clinical-trial-plant-derived-cannabis-preparation-is-safe-and-effective-in-children-with-autism/) 📰 Primary source: Keating BA, Ogru Y, Isikgel E, Sharma K, El-Sukkari D, Fahey MC. NTI164, a novel medicinal cannabis extract, improves core symptoms of autism spectrum disorder: results from a double-blind, randomised, controlled trial (The Harmony study). *Neurotherapeutics*. 2026;23(5):e01033. PMID 42561512. [doi:10.1016/j.neurot.2026.e01033](https://doi.org/10.1016/j.neurot.2026.e01033)Funding and author affiliation: the trial was funded by Fenix Innovation Group and Neurotech International; the first three authors are affiliated with Fenix Innovation Group. Further Reading CED Clinic Blog[Why Cannabis Works](https://cedclinic.com/why-cannabis-works/) Evidence Watch[Cannabis and Heart Health](https://cedclinic.com/cannabis-cardiovascular-health-study/) CED Clinic Blog[Cannabis for Sleep](https://cedclinic.com/cannabis-for-sleep/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) RELATED READING AT CED CLINIC Continue exploring the evidence [Study Finds CBD Improves Social Deficits, Hyperactivity and Repetitive Behaviors in Autism Model](https://cedclinic.com/study-finds-cbd-improves-social-deficits-hyperactivity-and-repetitive-behaviors-in-autism-model/) Explore how CBD impacts social and behavioral symptoms in autism models, complementing findings on cannabis extracts. [Read Study](https://cedclinic.com/study-finds-cbd-improves-social-deficits-hyperactivity-and-repetitive-behaviors-in-autism-model/) [Clinical Trial: Plant-Derived Cannabis Preparation Is Safe and Effective in Children with Autism](https://cedclinic.com/clinical-trial-plant-derived-cannabis-preparation-is-safe-and-effective-in-children-with-autism/) Review clinical trial evidence supporting the safety and efficacy of plant-derived cannabis preparations in pediatric autism care. [Learn More](https://cedclinic.com/clinical-trial-plant-derived-cannabis-preparation-is-safe-and-effective-in-children-with-autism/) [New Clinical Insights on Cannabis and Patient Outcomes](https://cedclinic.com/new-clinical-insights-on-cannabis-and-patient-outcomes/) Gain broader clinical insights on [cannabis use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) and its impact on patient outcomes across various conditions. [Explore Insights](https://cedclinic.com/new-clinical-insights-on-cannabis-and-patient-outcomes/) #### 📄 Printable 1-Page Physician Patient Guide Download or print Dr. Benjamin Caplan’s official clinical reference guide to share with your healthcare team. ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).