# PleoPharma Announces 1st Patient Dosed in Phase 3 Clinical Trial for Cannabis Use Disorder > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/pleopharma-announces-1st-patient-dosed-in-phase-3-clinical-trial-for-cannabis-use-disorder/ > **Published:** 2026-06-19T17:08:31-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:51:29-04:00 > **Clinical Summary:** PleoPharma's Phase 3 cannabis use disorder treatment trial begins dosing. Clinical implications for CUD pharmacotherapy and what clinicians should monitor. --- ✦ New CED Clinical Relevance #67 Notable Clinical Interest Emerging findings or policy developments worth monitoring closely. ResearchMental HealthCBDSafetyDosingIndustryHemp Why This Matters Clinicians currently lack FDA-approved pharmacotherapy for [cannabis use disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/), relying instead on behavioral interventions alone, making this Phase 3 trial potentially significant for expanding treatment options for patients struggling with dependence. If PleoPharma’s hemp-derived cannabinoid candidate demonstrates efficacy and safety, it could provide clinicians with a pharmaceutical tool to address withdrawal symptoms and reduce relapse rates in this patient population. This development is relevant to clinical practice because [cannabis use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) disorder affects millions of patients and often co-occurs with other psychiatric conditions that clinicians must manage. Clinical Summary PleoPharma has initiated a Phase 3 clinical trial evaluating a hemp-derived cannabinoid treatment for [cannabis use disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/), advancing toward potential FDA approval of a novel pharmacological intervention for this prevalent and undertreated condition. This represents a significant development in [addiction medicine](https://cedclinic.com/cognitive-flexibility-alcohol-cocaine-misuse-effects/), as [cannabis use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) disorder currently lacks any FDA-approved medications, leaving clinicians with limited pharmaceutical options beyond behavioral interventions and psychosocial support. Phase 3 trials typically involve larger patient populations and are the critical final step before regulatory review, making this milestone noteworthy for the field’s movement toward an evidence-based pharmaceutical option. If successful, approval of a cannabinoid-based treatment could expand the therapeutic toolkit for managing [cannabis dependence](https://cedclinic.com/ptsd-cannabis-dependence-veterans-social-support/), particularly for patients with severe withdrawal symptoms or comorbid psychiatric conditions who struggle with cessation using existing approaches. Clinicians should remain informed about this trial’s outcomes, as a new medication class for [cannabis use disorder](https://cedclinic.com/sex-differences-cannabis-stress-reactivity-oxytocin/) could substantially shift clinical practice in [addiction treatment](https://cedclinic.com/cannabis-based-therapies-smoking-cessation/) and primary care settings. Dr. Caplan’s Take “We’re at an early stage with this Phase 3 trial, so while it’s encouraging to see a pharmacologic approach to [cannabis use](https://cedclinic.com/cannabis-cardiovascular-health-insights-2024/) disorder advancing, we need to see the full data before drawing clinical conclusions. The early signals here are worth watching, but this is far from settled in terms of efficacy and safety in real-world populations.” Clinical Perspective 💊 The initiation of a Phase 3 clinical trial for a hemp-derived cannabinoid treatment of cannabis use disorder represents a potentially significant development in addressing a growing public health concern, though clinicians should remain cautious about premature enthusiasm given the early stage of this announcement and limited publicly available data on efficacy or safety. The paradox of using cannabinoid-based therapeutics to treat cannabis use disorder warrants careful consideration of mechanistic plausibility, as the specific pharmacological profile and dosing of investigational compounds may differ substantially from cannabis products patients encounter in real-world settings. Critical confounders include the heterogeneity of cannabis use disorder presentations, variable cannabinoid content in illicit and legal products, concurrent substance use, and psychiatric comorbidities that may influence both trial outcomes and clinical responsiveness. Until Phase 3 results are published in peer-reviewed journals and independently scrutinized, clinicians should continue relying on 💬 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/cannabis-related-research/) Have thoughts on this? Share it: [X Share on X](https://twitter.com/intent/tweet?text=Just%20read%20this%20on%20CEDclinic.com%3A%20PleoPharma%20Announces%201st%20Patient%20Dosed%20in%20Phase%203%20Clinical%20Trial%20for%20Cannabis%20Use%20Disorder%20%40drcaplan&url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D59738)[in Share on LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2F%3Fp%3D59738)[🦅 Share on BlueSky](https://bsky.app/intent/compose?text=Just%20read%20this%3A%20PleoPharma%20Announces%201st%20Patient%20Dosed%20in%20Phase%203%20Clinical%20Trial%20for%20Cannabis%20Use%20Disorder%20via%20%40drcaplan.bsky.social%20https%3A%2F%2Fcedclinic.com%2F%3Fp%3D59738)[📷 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 - [PleoPharma, Inc. Announces First Patient Dosed in Pivotal Phase 3 Clinical …](https://cedclinic.com/cannabis-withdrawal-syndrome-treatment-phase-3-trial/) - [What’s in My Weed?](https://cedclinic.com/whats-in-my-weed/) - [PleoPharma, Inc. Announces First Patient Dosed in Pivotal Phase 3 Clinical Trial of PP-01 …](https://cedclinic.com/pleopharma-inc-announces-first-patient-dosed-in-pivotal-phase-3-clinical-trial-of-pp-01/) 📰 Source: [https://www.cannabisbusinesstimes.com/home/news/15828093/pleopharma-announces-1st-patient-dosed-in-phase-3-clinical-trial-for-cannabis-use-disorder](https://www.cannabisbusinesstimes.com/home/news/15828093/pleopharma-announces-1st-patient-dosed-in-phase-3-clinical-trial-for-cannabis-use-disorder) 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. 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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 --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), 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).