Clarifying the legal landscape of psilocybin regulation: A medico-legal perspective
Drug Science Policy and Law April 1, 2025 Octavian Brinzei 1 citation
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Octavian Brinzei
3 papers in the library · 1 citation · publishing 2025-2026
Papers
MDMA and Psilocybin-Assisted Therapy in Australia: Early Real-World Prescribing, Safety Monitoring and Regulatory Developments
July 12, 2026 Octavian Brinzei
Australia became the first country to allow authorized psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression through the TGA Authorised Prescriber Scheme. By June 2025, there were 20 active MDMA and 17 psilocybin prescriber approvals; by December 2025, these grew to 48 and 40, increases of 140% and 135% respectively. From July 2023 to December 2025, 123 patients received MDMA-assisted therapy and 65 received psilocybin-assisted therapy. Despite growth, authorized prescribers represent about 1% of Australia's psychiatric workforce, indicating early-stage implementation.
The Brinzei MDMA-PTSD Protocol: Addressing the Food and Drug Administration’s Breaking Blind Concerns with Precision Approaches to Post-Traumatic Stress Disorder Treatment
Preprints.org October 3, 2025 Octavian Brinzei preprint
MDMA-assisted therapy reduces PTSD symptoms in multiple clinical trials, but regulatory rejection based on flawed blinding methods highlights a contradiction: the drug's strong psychoactive effects make true placebo-controlled trials impossible. This paper introduces the Trauma-Affective Memory Loop (TAML), a model of how traumatic memories are stored and reinforced. MDMA reduces fear signals, creating a temporary "therapeutic window" for safe trauma reprocessing. Acute, one-time traumas may resolve in one to three sessions, while complex or developmental trauma may need repeated treatment. A new quadruple-masked trial design, the Brinzei MDMA-PTSD Protocol (BMPP), limits bias while allowing effective therapy delivery.