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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.



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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Markets & Industry

Psychedelic therapy programmes launch to address heartbreak, burnout and more



Psychedelic therapy programmes launch to address heartbreak, burnout and more

Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges. 

Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.

All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.

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The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.

Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.

Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.

“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”

“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.

“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”

Additional Mastermind programmes will be released in the coming months, including: Getting Unstuck, by Dr Elizabeth Lombardo; Beating Burnout, by Dr Shauna Shapiro; and Coping with Cravings, by Dr Jud Brewer

“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.

“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”

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Psilocybin analogue shows positive results in Phase 2 depression study



Psilocybin analogue shows positive results in Phase 2 depression study

Cybin has announced positive Phase 2 topline safety and efficacy data for its proprietary deuterated psilocybin analogue – CYB003 – for the treatment of major depressive disorder (MDD).

Results from Cybin’s study have shown that 79% of patients were in remission from depression at six weeks after receiving two doses of CYB003.

CYB003 demonstrated a large improvement in symptoms after one dose and a total of 79% of patients were responsive to the treatment. The compound also demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to moderate and self–limiting.

Additionally, Cybin has stated that the magnitude of improvement was superior compared to approved antidepressants and recently reported data with other psychedelics, stating that the effects translate into an unprecedented effect size.

The company has said that the results compare favorably to pooled data from 232 industry studies of current standard-of-care antidepressants, SSRIs, submitted to the FDA.

The announcement follows Phase 2 interim results in early November 2023, which demonstrated that CYB003 saw a “rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo”.

Cybin CEO, Doug Drysdale, stated: “We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in four out of five patients in remission from their depression at six weeks.

“This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month.”

Drysdale emphasised that the strength of the data will support CYB003 into Phase 3 of the study.

Cybin CMO, Amir Inamdar, added: “The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying.

“At the three-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS. 

“This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. 

“These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). 

“With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Cybin is planning on submitting topline data to the FDA with an aim to hold a Phase 2 meeting in Q1 of 2024, with further 12-week durability data from Phase 2 CYB003 expected in Q1, and recruitment for the Phase 3 study anticipated to begin by the end of Q1 2024.

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Markets & Industry

Mychedelica launches to revolutionise psychedelic medicine



Mychedelica launches to revolutionise psychedelic medicine

A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field. 

With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.

Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.

CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.

“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”

mychedelica provides a comprehensive range of services, including:

Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.

Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.

Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.

With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.

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