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Could Italy decriminalise psychotropic substance cultivation? 

Psychedelic Health speaks with co-founder and international co-ordinator at Associazione Luca Coscioni, Marco Perduca, to find out more about what Italy’s campaign to decriminalise the cultivation of psychotropic substances means for the Right to Science.

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Study to evaluate psilocybin for cannabis use disorder

An Italian cannabis referendum could potentially lead to the decriminalisation of psychotropic substance cultivation, such as cannabis and mushrooms, for personal use if successful. 

The campaign has gained more than half a million signatures supporting the decriminlisation of psychotropic substance cultivation in less than a week, the amount needed to see a potential vote on the referendum. 

Focusing on the decriminalisation of cannabis cultivation and removal of sanctions for conduct related to cannabis, the campaign aims to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in the Presidential Decree 309/1990.

This would not lead to the legalisation of all substances, however, the campaigners say

“…eliminating the word “cultivate” decriminalizes the cultivation of all narcotic substances. However, this does not mean legalizing all drugs. In fact, the cases of illicit production, manufacture and possession remain and can also be applied to the farmer who produces for the purpose of selling.” 

They go on to say: “It is also worth remembering that with the exception of cannabis inflorescences (and mushrooms), all other narcotic substances necessarily require subsequent steps for the substance to be consumed, activities which continue to be punished in Article 73.” 

The right to cultivation

The campaign is spearheaded by Forum Droghe, Meglio Legale, Antigone, Luca Coscioni Associations, Società della Reagione, and supported by parties including Volt Italia, Possible, Italian + Europa, and the Communist Refoundation. Its launch follows a proposed referendum launched by Riccardo Magi to decriminalise cannabis cultivation.

Commenting on the campaign, president of the Organising Committee for the Cannabis Referendum, and co-founder and international co-ordinator at Associazione Luca Coscioni (Science for Democracy), Marco Perduca, said: “Associazione Luca Coscioni has been following all drugs-related issues since inception some 20 years ago. It is a splinter group of the only seriously anti-prohibition political party in Italy called Radical Party that, since the mid-60s, has been advocating the decriminalisation or legalisation of all substances. So it came naturally. 

“The moment we understood that signatures for a national referendum could be collected online, we put our conviction to the test, and because over the last five, six years, the debate on cannabis in particular, has grown exponentially, especially on social media and among the youngsters, and also in some cultural and musical quarters.

“I think our assumption was correct, because in five days we collected over 500,000 signatures, and, in order to qualify for a ballot next year, we needed the 500,000.”

Perduca, who was a senator in Italy from 2008 to 2013 and expert on UN mechanisms with an emphasis on drug policy reform, continued: “Now the process hasn’t stopped yet, but we are confident, and if the bureaucracy doesn’t slow down, and it doesn’t create obstacles, we’re good to go out on the 30 September to the Cassation Court to submit everything, then the Constitutional Court will have to take a decision in January. 

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“Our Constitution allows national referenda, provided they don’t touch the Constitution, they don’t touch the fiscal system and they don’t infringe with the ratification of international documents. Because cannabis, like all the other narcotics, is at the centre of an international drug control system, we decided to eliminate sanctions and criminal and administrative sanctions that did not have anything to do with the three UN conventions, so, we are confident that at least on that, there are no problems. 

“We know that the jurisprudence of the court in the past has been critical of the so-called manipulation of texts, so that sometimes you take away one word, and the entire architecture of the law crumbles down. We discussed this with jurists and experts in constitutional law, and we believe that this is the minimum that we could prepare, but the maximum in terms of the facts.

“We are, so to speak, liberating any kind of cultivation, but we are not deleting the verbs that are “produce” and “fabricate” which in Italian could mean “manufacturer”, so it would be okay to grow, but the moment in which you transform what you’re growing into something else it will be penalised.

“Now of course, this includes mushrooms and peyote – certainly for personal use, if that is not taken somewhere else and does not become something else – we are creating a new framework. Many of the substances that are in the same scheduling as cannabis have – and we know because of scientific literature that is being developed these days – very efficient and effective therapeutic implications. So, we hope that, by taking away the penalties, we take away the stigma. We have already started several campaigns.”

The Right to Science

Perduca emphasises that the issue spans further than an individuals’ right to cultivate and consume psychotropic substances for personal use, but that these restrictions interfere with the Right to Science. 

“We are also now pushing not only to allow people to grow, but also to use, what can be grown without problems for specific scientific research that is targeting specific physical conditions or pathologies because Italy is behind a lot of other countries in this kind of research. We only have one centre at the University of Rome that is starting to study psilocybin for therapeutic purposes. We also grow cannabis for medical reasons, but nobody’s studying it,” says Perduca. 

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“We hope that after next spring, if all goes well, there is going to be a new scenario, culturally, but also scientifically and then we can keep on insisting on this. So, we are taking away penalties for growing, but it depends on what you grow and how you use them.

“We are now working on something that is called the “Right to Science”, which is a not too well-known right enshrined in the International Covenant on Economic, Social and Cultural Rights, which entered into force in 1976, so it is not a new thing.

“What is new is that the UN at the Committee on Economic, Social and Cultural Rights in April 2020 adopted the general comment on Article 15 of the covenant, which is called General Comment 25 on Science

“There are three elements of the Right to Science including freedom of research, regardless of the topic research, the sharing of knowledge which is open access, free science, and free and open data are part and parcel of this right, and the last element of the Right to Science is the right to benefit scientific progress and its application. 

“The General Comment speaks clearly, it has one paragraph dedicated to cannabis as the example where prohibitionist laws have impeded research on the plant. It says that if you keep on insisting on limiting or prohibiting certain kinds of presences in the scientific sphere, you’re violating the right to science.

“There is another paragraph about the precautionary principle that says that if you have imposed restrictions for a limited amount of time because you fear that a new thing should be regulated in a way in which shouldn’t create harm to humans, animals or the environment, and after five, 10, 20, or in this case we are talking about 60, years – if you have seen that no such harm has been produced, then you have to upgrade or update those laws. In economic circles it’s called the Innovation Principle, here, it is an adjustment to the precautionary principle to the new general situation substantiated by scientific evidences.

“We have a lot of evidence that has been produced by groups like MAPS that has been produced over the last few years on MDMA and also cannabis. You have also other studies that say these substances regulated under the three UN conventions have become a threat because they are prohibited, not because they are dangerous in themselves.

“And so, scientific research for therapeutic uses should be taken into consideration but also statistics and criminology that will tell you that perhaps regulating the presence of these plants in our life in a different way could trigger different scenarios, and if we were to judge from the evidence that is coming from the US states or Canada or Uruguay, where you have contained the phenomenon, you will have to say that this type of evidences will need to be taken into consideration, certainly at the national level but one day possibly also at the international level.”

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Associazione Luca Coscioni has a publication coming out next week – The Dose Makes the Poison – which is a collection of presentations and international symposia it has conveyed over the last four years with psychedelic pioneers such as Amanda Feilding, Rick Doblin, Ben Sessa and Carl Hart. 

“In order to assist each other, together with the researchers, we are planning on launching a World Coalition for the Right to Science, to frame this according to existing international law, in order to go to the United Nations and show there is a contradiction between what the UN Convention on Drugs says, and the new clarification of the elements of the Right to Science.

“The three UN conventions were adopted to allow access to these plants and to the medicines that can be derived from them. At the same time, a punitive system was created if those plants and substances are not used for medical purposes. Now, the non-medical purposes have taken over in terms of our culture. While there is no problem, at least in my view, to do whatever you want to do, as long as you know what you’re doing and what you’re getting and so, it is a matter of personal responsibility, but it has to be informed decision, of course. But this stigma has percolated into the other domains which are science and medicine. We have to not only separate the two, but possibly make dialogue for the betterment of welfare and wellbeing at the global level.”

Perduca says the coalition should be ready to launch in November, and will be working at a global level not only on drugs but also on other issues such as genome editing, global warming and women’s rights.

ReferendumCannabis thinks the campaign to legalise the cultivation of psychotropic substances in Italy will gain the extra signatures needed to secure reviewal by the house. 

Società della Ragione, which attributes the success of the campaign so far to the ability to use digital signatures, describing their use as “a possibility unique for the practice of direct democracy by telematic means”, says that cannabis cultivation is a theme that “crosses justice, public health, safety, business opportunities, scientific research, individual freedoms and, above all, the fight against the mafia.”

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Research

Landmark UK trial to investigate psilocybin for opioid addiction relapse

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For the first time, a government-funded UK trial will investigate psilocybin-assisted psychotherapy for targetting relapses associated with opioid addiction, aiming to bring an innovative new therapy to the NHS if successful. 

Research shows that the UK had the world’s highest rate of opioid consumption in 2019, amounting to a serious public health concern. Further, figures show that around 140,000 people are accessing treatment for opioid dependence in the country. Despite the prevalence of opioid addiction, there are currently limited medicines to help prevent relapses during recovery.

Led by Imperial College London, the new study will use psilocybin combined with psychological support in people who have recently undergone detoxification from opioids such as heroin, methadone or buprenorphine.

While previous research into psilocybin has shown its potential as a treatment for conditions such as depression, anxiety PTSD and addiction, this is the first trial looking at the medicine for addiction relapse.

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The study is one of four projects focused on reducing drug deaths that have been funded by the National Institute for Health and Care Research (NIHR) as part of the Addiction Healthcare Goals programme, led by the Office for Life Science (OLS). 

According to the NHIR, the programme forms part of the Department of Health and Social Care’s plan to deliver a world-class treatment and recovery system for people experiencing drug and alcohol addictions.

Dr David Erritzoe, Clinical Director and Deputy Head of the Centre for Psychedelic Research at Imperial College London, project co-lead, said in a press statement: “We know that up to 90% of people relapse back to opioid use within 12 months of finishing detox, so finding new and effective treatments is essential. 

“If this trial is successful, it offers hope for a new type of treatment that could make a significant difference to this group of people.

“If our initial trial is successful, we will work to enable the development of further clinical trials in larger populations, to bring a new treatment to patients and the NHS.”

Participants will attend Imperial’s NIHR Clinical Research Facility at Hammersmith Hospital campus to receive psilocybin-assisted psychotherapy and will receive functional MRI brain scans to enable investigation of the mechanisms of psilocybin in the brain.

Imperial has confirmed that participants will be monitored for up to six months following dosing to track any changes to their opioid use, cravings, mental health outcomes and psychological wellbeing. 

Study co-lead Dr Louise Paterson said in a press statement: “This trial will examine whether we can improve recovery in a severely under-served group of people – namely, those with opioid dependence during their most vulnerable post-detox phase. 

“Clinical studies, including those in our Centre for Psychedelic Research, have shown great promise for this type of treatment in other mental health conditions. We want to see if it works equally well for opioid use disorder.”

Professor Anne Lingford-Hughes, Chair of the Addiction Healthcare Goals, and who is also a Professor of Addiction Biology at Imperial, added: “New approaches to treat drug addiction and reduce drug-related deaths, particularly from overdose, are urgently needed. 

“The Addiction Healthcare Goals programme is pleased to fund promising innovations that have brought together partnerships between industry, academia and organisations involved in delivering treatment and care for those experiencing drug addictions.” 

Recruitment is expected to begin in Spring 2025.

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Policy

European Citizen Initiative in support of psychedelic therapies to launch in 2025

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The European Citizens’ Initiative for Psychedelic-Assisted Therapies – launching at the start of 2025 – is aiming to collect one million signatures to urge the European Commission (EC) to take action on psychedelic-assisted therapies.

There are 150 million people in Europe living with a mental health condition, according to the World Health Organization (WHO). While there are treatments available, there has been no innovation in this area for over 50 years, and the treatments do not work for everyone.

For example, 10 to 30% of patients with major depressive disorder are resistant to currently available treatments, highlighting an urgent need for new therapies.

Adding to this, data from the Organisation for Economic Co-operation and Development (OECD) shows that mental health conditions cost the European economy up to €600 billion a year.

However, in recent years, increasing scientific research has shown psychedelic-assisted psychotherapy as an innovative and effective treatment for conditions such as depression, anxiety, addiction, and post-traumatic stress disorder (PTSD).

This mounting evidence has led to changes in policy and psychedelic access in countries such as Australia and Canada, where authorised patients are now able to access safe, legal psychedelic therapies.

Against this backdrop, the European Citizens’ Initiative for Psychedelic-Assisted Therapies has launched to urge the EC to support the future roll-out of psychedelic-assisted therapies in European healthcare systems.

The initiative is backed by 24 organisations, associations, researchers, therapists, patients, and citizens from 17 European countries, that are supporting the right of EU citizens to access affordable psychedelic-assisted therapies.

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From 14 January 2025, the campaign will have one year to collect one million signatures from at least seven EU Member States in order to formally call for action from the EC. If the campaign collects the signatures successfully, the EC will have six months to respond to the initiative.

“With the launch in January begins a year-long campaign that can bring hope to millions of European citizens suffering from mental health problems,” commented Théo Giubilei, Founder of the PsychedeliCare Initiative.

Dr Rayyan Zafar, Chair of the recently launched Psychedelic Industry UK, which is also backing the initiative, commented: “On behalf of Psychedelic Industry UK, we welcome the launch of the First European Citizens’ Initiative for Psychedelic-Assisted Therapies, a pivotal step in addressing the growing mental health crisis in Europe.

“With the mental health burden rising across the continent and an increasing body of scientific research supporting the efficacy of psychedelic-assisted therapies (PAT), public support for this initiative is essential.

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“Psychedelics, when used in a controlled, therapeutic setting, have shown remarkable potential in treating conditions such as depression, PTSD, addiction, anxiety, and other neuropsychiatric disorders which have reached epidemic proportions globally. However, regulatory barriers continue to limit their integration into modern healthcare.

“Public engagement can be a powerful catalyst for change, as we’ve seen in the UK with cannabis regulations. A groundswell of public support was instrumental in shifting political conceptions, leading to regulatory reform.

“A similar trajectory is possible for psychedelic therapies, but it requires broad public endorsement to pressure policymakers into action.

“This initiative presents an unparalleled opportunity for regulatory authorities to engage with the growing evidence base supporting psychedelic-assisted therapies. By doing so, we can develop a comprehensive regulatory framework that not only facilitates access to these treatments under medical supervision but also ensures the highest standards of safety and efficacy.

“We have witnessed the strides made in North America and Australia where medical and regulated access models for psychedelics are being developed and are in fruition. Europe must not be left behind.

“The time has come for our regulatory systems to reflect the scientific advancements in the field, many of which were discovered here, to improve patient access to life-changing therapies, and help tackle the escalating mental health crisis in Europe.

“This initiative is not just about signatures. It is about creating a movement that encourages policymakers to embrace innovation and evidence-based solutions in mental health care.

“I urge the public, professionals, and advocates across Europe to support this campaign.”

Organisations from across France, Croatia, the Netherlands, the Czech Republic, Italy, Portugal, Sweden, Greece, the United Kingdom, Ireland, Spain, Switzerland, Belgium, Estonia, and Poland are backing the campaign.

To find out more and to join the network, visit the official initiative website psychedelicare.eu.

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Research

Psilocybin versus escitalopram for depression shows positive results

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Compass Pathways launches Phase 3 psilocybin trial in UK

A six-month follow-up study of a Phase 2 clinical trial investigating psilocybin versus escitalopram for the treatment of major depressive disorder has shown positive results.

Around 30% of people living with depression in the UK are resistant to current treatments, highlighting an urgent need for new therapies. As the researchers of this study highlight, even for patients who have had their depression successfully treated, there is a high risk of relapse, with one in three patients relapsing within the year.

Equally, SSRI treatments often include side effects such as sexual dysfunction, weight gain, fatigue, and emotional blunting.

The authors note that a key consideration of any treatment of major depressive disorder “is its capacity to produce sustained antidepressant response or remission.”

Mounting evidence is increasingly pointing to psilocybin-assisted therapy as an innovative new treatment for the condition, with clinical trials showing that the therapy is capable of producing rapid and long-lasting antidepressant effects.

However, while clinical trials have investigated the treatment itself, they have not compared the treatment to the current gold standard in depression medications or looked at the long-term effects of the treatment.

This Phase 2 trial is the first to compare the long-term antidepressant effects of these two treatments alongside mental health measures including work and social functioning, connectedness, and meaning in life. 

In the trial, patients with major depressive disorder recruited from a UK hospital were administered either two doses of 25mg of psilocybin along with psychological support, or a six-week course of the selective serotonin reuptake inhibitor (SSRI) escitalopram in combination with psychological support.

The findings, published in eClinicalMedicine, revealed that both administered treatments saw sustained improvements in depressive symptoms, however, patients who were administered psilocybin-assisted psychotherapy saw greater lasting improvements. 

These improvements included psychosocial functioning, meaning in life, and psychological connectedness.

Dr James Rucker, Consultant Psychiatrist & Senior Clinical Lecturer in Psychopharmacology, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, said: “The authors have tended to attribute differences observed in this study to comparative differences between the drugs themselves, however, it is also possible that the results reflect biased reporting between groups. 

“This is more likely here because A) studies involving psilocybin tend to attract those with positive preconceptions about psilocybin and negative preconceptions about conventional antidepressants, and B) study participants were unblinded during the long-term follow-up phase that is reported in the paper, so knew which condition they were allocated to.

“This said, the nature of depression varies hugely between individuals, and this calls for the development of a similarly varied suite of treatment paradigms. Psilocybin therapy is certainly a different paradigm of treatment to escitalopram. 

“The observation of similar levels of effectiveness to antidepressants here is encouraging to see alongside the much larger trials of psilocybin currently underway here in the UK, Europe and the US.”

The authors write: “Key limitations of the study include its suboptimal power to detect small but meaningful differences between treatments, missing data, the potential use of additional interventions during the follow-up period, and reliance on self-reported treatment assessments. 

“These factors may affect the interpretation of the study findings and should be considered when evaluating the results.”

With these considerations in mind, the researchers suggest that the findings warrant further investigation into psilocybin-assisted psychotherapy for the treatment of depression.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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