In the larger of Italy’s two registered psilocybin trials, every participant is given capsules and a five-day course of magnetic stimulation to the brain. One of the two is a dummy, and neither they nor the study doctors are told which.
Outside the trials, a 2017 decree sets the conditions under which a doctor, with an ethics committee’s approval, may seek a medicine still in trials for a patient.
The health ministry funds both trials
The Università “G. d’Annunzio” (opens in new tab) of Chieti-Pescara sponsors both studies, and one Ministry of Health grant under Italy’s recovery plan, financed by the EU’s NextGenerationEU, funds them. Italy’s national health institute, the Istituto Superiore di Sanità (opens in new tab), says it coordinates the project. Italy authorised both through the European trials system, with its medicines agency, AIFA (opens in new tab), as the national authority and an ethics committee’s review.
A trial tests a question, and taking part is not the same as being treated. Neither study advertises for participants. The teams find them through outpatient clinics and referrals from specialists, decide who can join using each protocol’s criteria, and tell them in the information sheets that the treatment will not be available after the trial ends.
PRIDE, the larger trial: psilocybin compared with magnetic stimulation
- The name
- from the full title, Advancing PRecise Interventions for resistant DEpression. The register’s public title is PSILO-MODULATION.
- What it asks
- a first test of whether two doses of psilocybin are no worse than five days of accelerated, MRI-guided magnetic stimulation, within a margin set in advance
- Who it is for
- adults aged 18 to 65 with major depression that has not responded to at least two antidepressants. People with a psychotic disorder, a history of seizures, a substance use disorder, or who are pregnant or have recently given birth are among those excluded, and the protocol lists more.
- How it compares
- half receive psilocybin capsules with sham stimulation, half receive real stimulation with placebo capsules, assigned at random
- Planned participants
- 68
- Sites
- Chieti, Colleferro (ASL Roma 5), Foggia
- Phase
- II
- Authorised
- 8 July 2025
- Recruitment started
- 23 January 2026
- Record
- EU trials register, 2024-519844-34 (opens in new tab)
- In Italian
- Istituto Superiore di Sanità (opens in new tab)
TEMPO, the smaller trial: psilocybin after trazodone
- The name
- from the register’s public title, Trazodone’s Effects on Moderation of Psilocybin Outcomes.
- What it asks
- whether trazodone, another medicine, can be given safely at three rising doses before psilocybin; how the body handles the two; and, as an early signal only, whether trazodone dampens psilocybin’s effects on consciousness
- Who it is for
- adults aged 18 to 65 with major depression that has not responded to at least two antidepressants, who are fluent in Italian. People with a psychotic or bipolar disorder, serious heart or blood-pressure problems, or a pregnancy are among those excluded, and the protocol lists more.
- How it compares
- there is no comparison group; everyone taking part receives both medicines once, under medical supervision in hospital
- Planned participants
- 30
- Site
- Chieti
- Phase
- IIa
- Authorised
- 14 August 2026
- Recruitment started
- 15 August 2026
- Record
- EU trials register, 2025-523346-27 (opens in new tab)
The capsules come from Canada under import permits
The psilocybin capsules, PEX010, contain a dry extract of the mushroom Psilocybe cubensis, and Filament Health says it makes them (opens in new tab) in Canada. Red Light Holland bought the company in April 2026 (opens in new tab) and renamed itself Rhelion Life Sciences (opens in new tab) in August 2026. Both study protocols, filed in the register for PRIDE (opens in new tab) and TEMPO (opens in new tab), name Filament, in Canada, as the supplier and describe shipment to the hospital pharmacies, TEMPO’s by temperature-controlled courier.
PRIDE’s protocol says a company on the Ministry of Health’s list of firms authorised to use narcotics will bring the shipments in. Under article 50 of Italy’s drugs law (opens in new tab) each import needs its own permit, and the hospital pharmacy records the psilocybin in a narcotics register (opens in new tab) when it arrives and again when it goes to the study team. The same product is listed in registered trials in six other EU countries.
Filament Health, Canada
(maker, company statement)
An EU import and batch release of an investigational medicine
(EU clinical-trials regulation, 536/2014)
A company authorised to use narcotics, chosen from the Ministry of Health’s list
(PRIDE protocol; DPR 309/1990 art. 36)
An import permit for each shipment, valid six months
(art. 50)
The hospital pharmacy’s narcotics register
(art. 60)
For a group planning its own trial, the Ministry of Health describes the authorisation it can give universities under article 49 of the drugs law (opens in new tab) as covering scientific research and pre-clinical experimentation, and routes supply for clinical trials through companies authorised under article 36.
No compassionate-use case is publicly reported in Italy
Psilocybin has no marketing authorisation in Italy, so a doctor cannot prescribe it, even off-label, as Luca Pani (opens in new tab), a former director general of AIFA, has pointed out. Italy’s compassionate-use decree (opens in new tab) sets the conditions for giving a medicine still in trials outside a trial, to a single named patient or to a group under a company programme. The medicine must be in phase III trials, ongoing or finished, for the same condition, or, where the patient’s life is in danger, have finished phase II trials, with data from them good enough to judge it effective and tolerable.
The patient must have a serious or life-threatening illness and either no valid alternative treatment or no way into a clinical trial. The decree also covers patients continuing, after a concluded trial, a treatment that helped them, and the conditions are assessed for the specific medicine requested.
The request comes from a doctor, or from several doctors for a group, and an ethics committee approves or refuses it and sends its opinion to AIFA. The manufacturer has to agree to supply the medicine at no charge. The decree lets the border health office admit a medicine from abroad on the ethics committee’s opinion, but its text does not mention the drugs law and the permit that law requires for every import of a narcotic.
AIFA’s published list of compassionate-use programmes (opens in new tab) names no psilocybin programme. Approvals for single patients are sent to AIFA but not published, and no source we found reports anyone in Italy treated this way. In Germany, Rhelion says (opens in new tab) the same capsules have gone to patients in a compassionate-use programme since April 2026. Psilocybin sold online or offered at retreats, in Italy or abroad, is part of neither route.
Italy’s drugs law lists the mushrooms by name
Italy’s schedule of controlled substances, Tabella I (opens in new tab), lists psilocybin and psilocin, and on a line of its own funghi del genere strofaria, conocybe e psilocybe: mushrooms of three named genera. Without an authorisation from the Ministry of Health, growing them, selling them or supplying them to others is a crime under article 73 of the drugs law (opens in new tab), and it can mean prison. A grow kit is not that authorisation.
Italy’s highest criminal court has held that very small home cultivation for the grower’s own use (Sezioni Unite 12348/2020 (opens in new tab)) and a purchase shared from the outset for joint use (Sezioni Unite 25401/2013 (opens in new tab)) fall outside that crime. Neither ruling concerned mushrooms.
Holding them for personal use is an administrative offence, dealt with by the prefect, the central government’s representative in the province, who normally imposes one or more sanctions for two months to a year, such as the suspension of a driving licence or passport, or a ban on obtaining one. For a first, particularly minor case, the prefect may instead close the matter with a formal warning. Whether an amount is for personal use is judged from the quantity of active substance against limits set by the Ministry of Health, the way it is packaged and the other circumstances, and in a criminal case by a judge. The Italy record carries the rest of the law.