Italy

Psychedelics are currently illegal in Italy, categorized under substances with psychotropic and narcotic effects. Nevertheless, ketamine stands as the sole psychedelic-related compound sanctioned for medical use, specifically in the form of esketamine nasal spray (Spravato), which gained approval in April 2020. This treatment is accessible strictly through a prescription from a medical professional. While research on psychedelics is limited and conducted on a modest scale, recent decriminalization movements could pave the way for more extensive studies in the future.

Author: This page has been made possible with the help of Chiara Corpetti, PhD in Pharmacology and Toxicology.

Psychedelics Research in Italy: A Brief History

Italy boasts a rich and pioneering history in psychedelic research throughout the 20th century, particularly in the clinical study of psilocybin, lysergic acid amide (LSA), and lysergic acid diethylamide (LSD) [1].

One of the earliest significant milestones in this field occurred in 1950 when Umberto De Giacomo conducted Italy’s first clinical trial on LSD involving psychotic patients. This trial was groundbreaking, as it marked the first instance of administration of a high oral dose of 500 μg of LSD to human subjects.

Building on this early work, further research was conducted between 1956 and 1957, marking a new phase in the study of psychedelics. During this period, the University of Rome hosted the first study that combined LSD and LSA. Researchers, such as Callieri and Ravetta, observed that LSA produced more sedative effects, whereas LSD had more hallucinatory characteristics. These findings offered valuable insights into the differing efficacy profiles of these two substances.

In 1960, Italy advanced its research into psilocybin when Balestrieri conducted the country’s first study on psilocybin. This research, involving both oral and intramuscular administration, was particularly noteworthy for its exploration of cross-tolerance between psilocybin and LSD, contributing to a deeper understanding of the interplay between these two psychedelics. Parallel to developments in psychedelic research, Italy made contributions to migraine treatment using lysergic compounds.

Between 1927 and 1966, Federico Sicuteri, a researcher at the University of Florence, investigated the anti-migraine effects of LSD at non-hallucinogenic doses. His studies revealed that low doses of LSD had a prophylactic effect, significantly reducing or even preventing migraine episodes. He also collaborated with Marcello Fanciullacci, who, in 1975, published research showing that LSD, along with ergotamine and methysergide, enhanced the vasoconstrictive effects of serotonin. This marked another breakthrough in migraine treatment.

Overall, Italy has played an early and pioneering role in advancing psychedelic research. Its contributions have aligned with broader European scientific efforts while also pioneering key areas of study, particularly in psychiatric research and clinical applications of these substances.

Psychedelics in Italy Today

In September 2021, activists reportedly gathered the necessary 500,000 signatures to begin qualifying a ballot measure aiming to decriminalize the personal cultivation and use of not only marijuana but also psilocybin mushrooms and certain other psychoactive plants. The Italian public showed significant support for the effort to challenge the state’s restrictions on the use of psychoactive substances of natural derivatives. Although the initiative garnered substantial public support, the Constitutional Court ultimately blocked the referendum, citing violations of Italy’s obligations under international treaties on drug control, thereby preventing a potential nationwide vote in spring 2022 [3].

Subsequently, in March 2022, the Italian Ministry of Health classified both Banisteriopsis caapi and Psychotria viridis – the two plants from which ayahuasca and the psychoactive DMT are derived – as highly controlled substances.

Viviana Trezza from Roma Tre University, in 2023, in collaboration with Nova Mentis, is actively exploring the use of psilocybin in treating autism spectrum disorder (ASD). Through animal models, Trezza and her team observed early evidence of psilocybin’s potential to mitigate anxiety-like behaviors associated with ASD.

In the same year, Roberto Ciccocioppo from the University of Camerino conducted a preclinical study using psilocybin in animal models with alcohol use disorder (AUD). His research revealed that psilocybin reduces alcohol-seeking behaviour, likely by disrupting memory processes linked to alcohol use [3].

Most recently, in September 2024, the European Commission approved PsychedelicCare, an initiative promoting the medical use of psychedelics across the European Union (EU). This initiative is supported by the Luca Coscioni Association – a non-profit organization advocating for free scientific research and civil liberties – along with SIMEPSI, Italy’s first scientific society dedicated to research on the application of psychedelics. This initiative is set to begin collecting signatures to further support its cause.

As one of the leaders in this movement, Italy continues to play an instrumental role in advancing the acceptance of psychedelics for medical purposes across the EU.

Key Organisations

Psycore, The Italian Multidisciplinary Network for Psychedelic and Consciousness Research, is a non-profit dedicated to exploring altered states of consciousness. Founded in 2019 in Turin, Psycore aims to promote the sharing of knowledge, the development of initiatives, and synergetic activities dedicated to further exploring psychedelics and their potential. Their most recent event, Stati Generali della Psichedelia in Italia 2021, was a gathering of like-minded individuals discussing the state of psychedelic science in Italy.

The Società Psichedelica Italiana (Italian Psychedelic Society) is another non-profit in Milan that promotes scientific research on psychedelic substances, integration between various knowledge systems, harm reduction practices, evidence-based regulatory reform, and the protection of cultures and nature.

References

1. D’Arienzo, A., & Samorini, G. (2023). Italian psychedelic therapies of the past century: An historical overview. Drug Science, Policy and Law, 9, 20503245231179687.

2. https://www.marijuanamoment.net/italian-activists-turn-in-more-than-half-a-million-signatures-for-marijuana-and-psilocybin-referendum/

3. Benvenuti, F., Colombo, D., Soverchia, L., Cannella, N., Domi, E., & Ciccocioppo, R. (2023). Psilocybin prevents reinstatement of alcohol seeking by disrupting the reconsolidation of alcohol-related memories. Psychopharmacology, 240(7), 1521-1530.