# Phase 2 Open-Label INSPIRE Trial on Transdermal CBD Gel in 22q11.2 Deletion Syndrome > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/transdermal-cannabidiol-gel-children-inspire-trial/ > **Published:** 2026-03-27T09:01:27-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:36:54-04:00 > **Clinical Summary:** Explore the INSPIRE trial assessing transdermal cannabidiol gel children with 22q11.2 deletion syndrome for tolerability and preliminary effectiveness. --- CED Clinical Relevance  #64Notable Clinical Interest  Emerging findings or policy developments worth monitoring closely. 🔬 Evidence Watch  |  CED Clinic CbdPediatricNeurodevelopmentalTransdermalOpen-Label Journal Journal of [neurodevelopmental disorders](https://cedclinic.com/medical-cannabis-gilles-de-la-tourette-syndrome-experience/) Study Type Open-Label Trial Population Human participants Why This Matters 22q11.2 deletion syndrome affects 1 in 4,000 births and presents with complex neurodevelopmental challenges including anxiety, ADHD, and behavioral dysregulation for which current treatments are often inadequate. This represents the first systematic evaluation of transdermal CBD in this specific genetic syndrome population. Clinical Summary This phase 2 open-label trial evaluated transdermal CBD gel (10mg/cm²) applied twice daily in children and adolescents with 22q11.2 deletion syndrome over 12 weeks. The study assessed tolerability as the primary endpoint, with secondary measures including behavioral rating scales and [quality of life](https://cedclinic.com/cannabis-policy-enforcement-february-26-2026/) assessments. Results demonstrated good tolerability with primarily mild skin reactions at application sites, while showing preliminary signals of improvement in anxiety and behavioral measures, though the open-label design limits definitive efficacy conclusions. Dr. Caplan’s Take “While encouraging for tolerability, the open-label design and lack of placebo control make it impossible to separate true therapeutic effects from expectation bias in this vulnerable population. The transdermal delivery system is intriguing for pediatric dosing precision, but we need controlled data before drawing clinical conclusions.” Clinical Perspective 🧠 Clinicians should view this as preliminary safety data rather than efficacy evidence for CBD in 22q11.2 deletion syndrome. Families interested in CBD should understand that controlled trials are still needed to establish therapeutic benefit, and any [cannabis medicine](https://cedclinic.com/essential-oils-industrial-hemp-antimicrobial-benefits/) use should involve specialized medical supervision with attention to [drug interactions](https://cedclinic.com/cannabis-liver-interactions-study-insights/) and developmental considerations. 💬 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? 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Share it: [𝕏 Share on X](https://twitter.com/intent/tweet?text=Just%20read%20this%20on%20CEDclinic.com%3A%20Phase%202%2C%20open-label%20INSPIRE%20trial%20to%20assess%20the%20tolerability%20and%20effectiveness%20o...%20%40drcaplan&url=https%3A//pubmed.ncbi.nlm.nih.gov/41888667/)[in Share on LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A//pubmed.ncbi.nlm.nih.gov/41888667/)[🦥 Share on BlueSky](https://bsky.app/intent/compose?text=Just%20read%20this%3A%20Phase%202%2C%20open-label%20INSPIRE%20trial%20to%20assess%20the%20tolerability%20and%20effectiveness%20o...%20--%20via%20%40drcaplan.bsky.social%20https%3A//pubmed.ncbi.nlm.nih.gov/41888667/)[📷 Follow on Instagram](https://www.instagram.com/drbenjamincaplan/)[📝 Read more on Substack](https://substack.com/@doctorapproved)[🔔 Subscribe via RSS](https://cedclinic.com/category/cannabis-news/feed/) 📰 Source: [https://pubmed.ncbi.nlm.nih.gov/41888667/](https://pubmed.ncbi.nlm.nih.gov/41888667/) Table of Contents - [FAQ](#FAQ)[What is the INSPIRE trial investigating in children with 22q11.2 deletion syndrome?](#What_is_the_INSPIRE_trial_investigating_in_children_with_22q112_deletion_syndrome) - [Why is transdermal CBD being studied instead of oral formulations?](#Why_is_transdermal_CBD_being_studied_instead_of_oral_formulations) - [What symptoms or conditions associated with 22q11.2 deletion syndrome might CBD potentially address?](#What_symptoms_or_conditions_associated_with_22q112_deletion_syndrome_might_CBD_potentially_address) - [What are the safety considerations for using CBD in children with 22q11.2 deletion syndrome?](#What_are_the_safety_considerations_for_using_CBD_in_children_with_22q112_deletion_syndrome) - [How significant are these findings for clinical practice?](#How_significant_are_these_findings_for_clinical_practice) - [Related](#Related) ## FAQ #### What is the INSPIRE trial investigating in children with 22q11.2 deletion syndrome? The INSPIRE trial is a Phase 2, open-label study examining the tolerability and effectiveness of transdermal cannabidiol (CBD) gel in pediatric patients with 22q11.2 deletion syndrome. This represents one of the first clinical investigations of topical CBD delivery in this specific neurodevelopmental population. #### Why is transdermal CBD being studied instead of oral formulations? Transdermal delivery may offer advantages including bypassing first-pass hepatic metabolism, providing more consistent drug levels, and potentially reducing gastrointestinal [side effects](https://cedclinic.com/cannabis-intoxication-memory-disruption/). This route could be particularly beneficial for pediatric patients who may have difficulty with oral medications or experience GI sensitivities common in neurodevelopmental conditions. #### What symptoms or conditions associated with 22q11.2 deletion syndrome might CBD potentially address? While the study summary doesn’t specify target symptoms, 22q11.2 deletion syndrome commonly involves anxiety, attention deficits, autism spectrum behaviors, and seizures. CBD has shown potential therapeutic effects for anxiety, behavioral regulation, and seizure management in other pediatric populations. #### What are the safety considerations for using CBD in children with 22q11.2 deletion syndrome? Children with 22q11.2 deletion syndrome often have complex medical profiles including cardiac anomalies, immune deficiencies, and multiple medications. The open-label design of this trial will help establish safety parameters and identify potential [drug interactions](https://cedclinic.com/cannabis-liver-interactions-study-insights/) specific to this vulnerable population. #### How significant are these findings for clinical practice? This study represents emerging evidence in pediatric CBD therapeutics for rare genetic conditions, warranting close monitoring by clinicians. While promising, the open-label design means results should be interpreted cautiously, and controlled trials would be needed before establishing standard clinical recommendations. {“@context”: “https://schema.org”, “@type”: “ScholarlyArticle”, “headline”: “Phase 2, open-label INSPIRE trial to assess the tolerability and effectiveness of transdermal cannabidiol gel in children and adolescents with 22q11.2 deletion syndrome (ZYN2-CL-031).”, “url”: “https://pubmed.ncbi.nlm.nih.gov/41888667/”, “about”: “journal [neurodevelopmental disorders](https://cedclinic.com/medical-cannabis-gilles-de-la-tourette-syndrome-experience/) open label trial”, “isPartOf”: “Journal of neurodevelopmental disorders”} [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 [Phase 2, open-label INSPIRE trial to assess the tolerability and effectiveness of transdermal cannabidiol gel in children and adolescents with 22q11.2 deletion syndrome (ZYN2-CL-031).](https://cedclinic.com/transdermal-cbd-22q112-deletion-syndrome-clinical-trial/) Detailed clinical trial data on transdermal CBD gel use in pediatric patients with 22q11.2 deletion syndrome. [Read the full trial report](https://cedclinic.com/transdermal-cbd-22q112-deletion-syndrome-clinical-trial/) [Is CBD Safe for Teens? Risks, Side Effects, and the Law](https://cedclinic.com/is-cbd-safe-for-teens-risks-side-effects-and-the-law/) An overview of safety considerations, [side effects](https://cedclinic.com/cannabis-intoxication-memory-disruption/), and legal aspects of CBD use in adolescent populations. [Learn about CBD safety](https://cedclinic.com/is-cbd-safe-for-teens-risks-side-effects-and-the-law/) [Cannabis affects childhood brain development, is 'real risk' for teens, UCSD finds in long-term study](https://cedclinic.com/cannabis-affects-childhood-brain-development-is-real-risk-for-teens-ucsd-finds-in-long-term-study/) Research findings on the impact of cannabis exposure on brain development during childhood and adolescence. [Explore developmental risks](https://cedclinic.com/cannabis-affects-childhood-brain-development-is-real-risk-for-teens-ucsd-finds-in-long-term-study/) ### 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).