Italy

Reimbursed as a hospital medicine (Classe H) since May 2022 for treatment-resistant depression (≥2 failed antidepressants, alongside an SSRI/SNRI), delivered at regionally authorized psychiatric centers under an AIFA monitoring registry. The separate psychiatric-emergency indication was classified Classe C in 2024 — not reimbursed.

Legal off-label under physician responsibility, but the market is minimal — Florence’s Istituto di Neuroscienze is the main listed provider; not reimbursed by the SSN for psychiatric use.

Strictly controlled under DPR 309/1990; no Italian psilocybin trial is recruiting as of July 2026.

Strictly controlled under DPR 309/1990; no Italian MDMA trial is recruiting.

Magistral preparations prescribable by any physician (framework: DM 9 November 2015; military-grown FM2 plus Bedrocan imports; regional reimbursement variation). Non-medical: personal use is an administrative offence; the decade-old ‘cannabis light’ low-THC retail market was banned by the 2025 Security Decree — now before the Constitutional Court.

Recruiting ketamine/esketamine studies in Milan, Turin, Brescia, Naples and Cagliari (incl. INTENSIFY). Participation is free; screening is strict; never pay for “trial access”.