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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. 

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

“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

Is connection key? How clinicians impact patient outcomes in psychedelic therapy

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A wealth of research is showing how psychedelic-assisted therapy holds promise for the treatment of mental health conditions such as depression, but what role does the therapist play in a patient’s outcome? A new study has suggested it may be a big one.

Psychedelics have piqued huge interest due to their effects on the brain. Research points to their ability to induce neuroplasticity in the brain as one of the key reasons they may help with conditions such as depression and anxiety.

However, set – the individual’s (or patient’s) mental state – and setting – the individual’s environment during a psychedelic experience – are hugely impactful on the outcome of these experiences.

In the traditional use of psychedelic medicines, shamans help to guide set and setting throughout the experience with singing, drumming and ritual. Today, in scientific research, trials, and in clinics, the clinician is essentially playing this role.

Senior author of a new study, Alan Davis, associate professor and director of the Center for Psychedelic Drug Research and Education in The Ohio State University College of Social Work, has highlighted that the impact of clinicians on patient outcomes is not new, with research consistently showing that a trusting relationship between patients and clinicians has been key to better outcomes. This concept is known as a “therapeutic alliance”.

Understanding the therapeutic alliance

To find out more about the impact of this therapeutic alliance in psychedelic therapy, researchers from Ohio State University College of Medicine analysed data from a clinical trial that investigated psilocybin-assisted psychotherapy for the treatment of major depressive disorder (MDD).

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In the trial, participants received two doses of psilocybin and 11 hours of psychotherapy, completing a therapeutic alliance questionnaire afterward, which assessed the strength of the therapist-participant relationship.

Participants also completed questionnaires about any mystical and psychologically insightful experiences they had during the drug treatment sessions. In psychedelic research, the mystical experience has often been shown to be related to the continuing positive effects of this therapy.

The Ohio team looked at the depression outcomes alongside patient reports about their experiences with the medicines as well as their connection with their therapists.

They found that a stronger relationship between patient and clinician led to a better clinical outcome for the patient – with improved depression scores up to 12 months following the experience.

Lead author Adam Levin, a psychiatry and behavioral health resident at Ohio State University College of Medicine, stated: “What persisted the most was the connection between the therapeutic alliance and long-term outcomes, which indicates the importance of a strong relationship.”

Analysis results revealed that over time, the alliance score increased, and in fact demonstrated more acute mystical experiences for the patient. The team also found that acute effects were linked to lower depression four weeks following treatment, but were not associated with better depression outcomes a year after the trial.

“The mystical experience, which is something that is most often reported as related to outcome, was not related to the depression scores at 12 months,” Davis stated.

“We’re not saying this means acute effects aren’t important – psychological insight was still predictive of improvement in the long term. But this does start to situate the importance and meaning of the therapeutic alliance alongside these more well-established effects that people talk about.”

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According to the team, the analysis showed that a stronger relationship during the final therapy preparation session predicted a more mystical and psychologically insightful experience – which in turn was linked to further strengthening the therapeutic alliance.

“That’s why I think the relationship has been shown to be impactful in this analysis – because, really, the whole intervention is designed for us to establish the trust and rapport that’s needed for someone to go into an alternative consciousness safely,” Davis stated.

“This isn’t a case where we should try to fit psychedelics into the existing psychiatric paradigm – I think the paradigm should expand to include what we’re learning from psychedelics,” Levin added.

“Our concern is that any effort to minimise therapeutic support could lead to safety concerns or adverse events. And what we showed in this study is evidence for the importance of the alliance in not just preventing those types of events, but also in optimizing therapeutic outcomes.”

The authors emphasised that efforts to minimise negative experiences in future studies of psychedelics is vital, and that therapy is critical to creating a supportive environment for patients.

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Policy

EMA workshop: One small step for Europe, one giant leap for psychedelics

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EMA workshop: One small step for Europe, one giant leap for psychedelics

In a watershed moment for psychedelics in Europe, the European Medicines Agency (EMA) held a workshop from 16 to 17 April to discuss regulatory guidelines for the development and therapeutic use of psychedelic medicines.

2024 is set to be an important year for psychedelics and the EMA multi-stakeholder workshop is just one of the key events kicking it into action.

The two-day workshop – Towards an EU Regulatory Framework – brought together patients, healthcare professionals, academia, regulators and industry.

As Europe risks lagging behind countries such as Australia and America in seizing the potential of psychedelics for mental health innovation, the meeting was held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on these therapies.

See also  EMA adds psychedelics to major depression guidelines

The MEPs wrote to the EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organizations need to play a more active role in the advancement of psychedelic medicines in Europe.

Highlighting that the recent shift in perspective towards psychedelics has garnered interest in Europe, the EMA has stated that concerns remain over challenges developers may face in meeting the scientific and regulatory expectations for receiving marketing authorisation for the medicines – holding the workshop as a starting point in working through these issues.

While the meeting marks one small, initial step for the EMA, the organisation’s interest in this developing field of research marks a giant leap for the advancement of the therapies in Europe.

Towards an EU regulatory framework for psychedelics

The meeting heard regulatory perspectives on psychedelic drugs in psychiatry from across Europe, Australia and America, as well as insights on the legal status of psychedelics and their impact on research.

Non-profit organisation PAREA highlighted how Europe is currently facing a mental health crisis with a desperate need for innovation in care, with not a single new medicine out of the 89 approved in 2022 targeting mental health.

The organisation emphasised the obstacles posed by regulation for scientific research and proposed a number of recommendations for a more supportive regulatory framework to help move psychedelic therapies forward, including:

  • Incentives such as regulatory protection: rescheduling psychedelic drugs to enable scientific research.
  • Enhanced EMA support: Utilising Europe’s PRIME scheme which focuses on medicines under development that are not yet authorised in the EU.
  • The establishment of an EU Commission on Novel Mental Health Therapies.
  • Accelerated assessments: Utilising Conditional Marketing Authorisation (CMA) and the EMA’s Adaptive Pathways programme for early patient access.
  • A more predictable reimbursement environment.

Speaking to Psychedelic Health, Tadeusz Hawrot, Founder and Director of PAREA, stated: “An importance of collaboration among different stakeholders felt central to the discussions, highlighting a need for joint effort to address the intricate issues surrounding psychedelic therapies.”

Building on the momentum created at the workshop, Hawrot said that PAREA will be exploring opportunities for a multistakeholder collaborative project as part of the Horizon Europe funding.

“The project would involve professional societies, patient groups, EMA and national competent authorities, addressing a number of most pressing topics related to psychedelic therapies at an intersection of regulation, science, and areas needed for implementing these therapies such as standards of care,” Hawrot explained.

“An upcoming EU Partnership on Brain Health will be an important opportunity to explore in this regard.”

Research and clinical trials

Further discussions focussed on methodological issues related to research and trials.

These surrounded issues with blinding and expectations, the importance of proper dosage justification and documenting dose-response relationships, as well as the need to investigate sub-psychedelic doses and their associations with psychoactive effects and neuroplasticity.

Hawrot commented: “In terms of some key areas addressed yesterday and today, discussion revolved around designing effective trials, the importance and type of therapeutic support, difficulties with using placebos, managing expectations, and how strict drug control policies are slowing down research.

“Exploring what can be standardised in trials, the crucial role of patient input and preferences, and the need for thorough aftercare provisions were further key points.”

The importance of Real World Evidence was also highlighted as a key path for advancing psychedelic therapies in Europe

Some implied next steps discussed were continuing dialogue between developers and regulators, seeking early feedback, and collaborating to address challenges in psychedelic drug development.

Patient representation and care

Ensuring the safe and effective use of psychedelic substances in clinical trials and real-world settings was also a main point of discussion, with patient representatives providing insight on their experience, as well as suggestions for patient care.

In particular, stakeholders including representatives of the Psychedelic Participant Advocacy Network (PsyPAN) highlighted the need for aftercare such as post-integrative therapy and peer support or professional guidance, however, it was also emphasised that these types of support are difficult to regulate.

The importance of patient involvement in research was also discussed, highlighting that patient involvement goes beyond study participation and includes a more active role in research design and decision-making.

Advancing innovation

Providing an environment where innovation can flourish will be vital for advancing psychedelics, and with companies already carrying out trails but hindered by strict regulations and expensive costs changes are needed sooner rather than later.

George McBride, Co-Founder of UK CMO Clerkenwell Health explained that the company is considering a significant investment into the EU to build out centres for the conduct of psychedelic research, querying the competitiveness of the EMA versus other jurisdictions such as the U.S FDA, Australia’s TGA, Health Canada and the UK’s MHRA.

EMA representatives provided assurance that the organisation is ready to be part of a collaborative and supportive effort to establish standards of care and standards for data gathering.

Speaking to Psychedelic Health, Stephen Murphy, CEO of PSYCH, commented: “This workshop is a key moment for the advancement of psychedelic medicines in Europe.

“The interest of the European Medicines Agency and the discussions in this week’s meeting highlights the organisation’s desire for innovation in mental healthcare and willingness to support psychedelic medicines through collaborative efforts.

“Taking action on psychedelic therapies now is a positive move towards preventative care in the area of mental health.

“We are pleased to see these developments at the start of 2024, which is set to be an important year for psychedelics across the globe.”

Harwot concluded: “The workshop made it clear that continuing conversations with regulators and developers and taking a measured approach to regulations are vital.

“It is very encouraging to see the degree of interest from EMA to explore the therapeutic potential of psychedelics and support developers in this field.”

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Research

Phase 2a trial to investigate 5-MeO-DMT candidate for alcohol use disorder

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Beckley Psytech and Clerkenwell Health are collaborating on a Phase 2a trial investigating Beckley’s synthetic 5-MeO-DMT candidate combined with psychological support as a treatment for alcohol use disorder (AUD).

AUD is estimated to affect around 237 million people across the globe and over 7.5 million people in the UK.

Treatment options for the harmful use of alcohol are not always effective – there are high relapse rates and there are around three million deaths each year attributed to the substance’s misuse.

Increasing research is showing that psychedelics may hold promise as innovative treatments for addiction, including substances such as ketamine and psilocybin.

See also  How psychedelics could help those living with alcohol use disorders

BPL-003 is Beckley Psytech’s short-duration and fast-acting synthetic formulation of 5-MeO-DMT – a psychedelic found in several plant species and the glands of at least one toad species – which is administered intranasally via an FDA-approved delivery device.

The compound has shown in Phase I data to be well-tolerated with a reproducible and dose-linear pharmacokinetic profile.

The Phase 2a trial

Beckley and Clerkenwell have confirmed that the collaborative Phase 2a open-label trial will evaluate the safety, tolerability and pharmacodynamic effects of a single dose of Beckley BPL-003 combined with abstinence-oriented psychological support in participants with AUD.

Currently taking place at King’s College London, Clerkenwell Health’s clinic near Harley Street, London, will provide an additional trial site.

According to Beckley, BPL-003 has been successful in eliciting psychedelic experiences of “similar intensity but shorter duration than psilocybin”.

Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, stated: “An estimated 600,000 people are dependent on alcohol in England. This, coupled with an alarming increase in alcohol-related deaths of 89% over the past 20 years, shows the status quo isn’t working.

“Conventional treatments for alcohol dependency aren’t producing meaningful improvements and new avenues must be explored. This trial will assess whether psychedelic-assisted treatment can be an effective therapy for alcohol use disorder, with the hope of rolling out the treatment widely.

“Health professionals and policymakers should seriously consider such treatments, which could be genuinely ground-breaking for the NHS and for the hundreds of thousands of people being treated for alcohol use disorder in the UK.”

Beckley Psytech and Clerkenwell have emphasised that the results of the trial may be used to provide support for further study of psychedelic-assisted treatment for alcohol dependency.

Dr Rob Conley, Chief Medical and Scientific Officer at Beckley Psytech, added: “We’re committed to developing a transformative and effective treatment option for individuals struggling with alcohol use disorder.

“Based on our preclinical and Phase I data, we are optimistic about the potential therapeutic benefits of BPL-003 for substance use disorders and we are excited to evaluate the compound further in this clinical trial.

“I want to extend my thanks to the team at Clerkenwell Health and King’s, as well as to the patients who have joined, and will join, this study. Their participation, support and collaboration are absolutely critical to furthering research into this area of huge unmet need.”

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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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