Posted on: 28 October 2024
Dr John R. Kelly writes how easing regulatory constraints would facilitate the advance of the scientific evidence underpinning psychedelics and psychedelic therapy
Psychedelic therapies are emerging as promising treatments for various mental health conditions, such as depression, post-traumatic stress disorder (PTSD), anxiety and substance-use disorders.Psychedelic research in Ireland is contributing to the global effort to gather high-quality scientific evidence to determine the therapeutic effectiveness of such therapy.
The recently formed Trinity College Dublin and Tallaght University Hospital Psychedelic Research Group (TTPRG) is working with several industry partners to conduct large-scale clinical trials of psychedelic therapy for people who suffer from treatment-resistant depression, PTSD and anorexia nervosa. Some of these clinical trials are also taking place in Galway.
TTPRG has also received public funding from the Health Research Board (HRB) to investigate how psychedelics may affect the immune system in depression, and separately, to explore the feasibility of psilocybin therapy as a potential treatment for cocaine-use disorder.
The HRB has also funded research into ketamine as an adjunctive therapy for depression (KARMA-DEP (2) Trial), currently taking place in St Patrick’s University Hospital in Dublin.
If this trajectory continues, Ireland is on course to be a vibrant ecosystem of education, training and innovation in psychedelic research. This growing and diverse inter- and cross-disciplinary collaborative research community in Ireland may also create opportunities for linking with international networks.
However, in Ireland, as in many parts of the world, the use of psychedelics for therapeutic purposes remains highly restricted, controlled by outdated regulatory frameworks. This can act as a barrier to the advance of high-quality scientific research into the potential therapeutic benefits of psychedelics. It is now time to re-appraise Ireland’s regulatory landscape.
One of the concerns surrounding psychedelic use is the potential for negative/challenging experiences.
At present, Ireland’s policy on psychedelic drugs is shaped largely by the Misuse of Drugs Act 1977, which classifies psychedelics, including psilocybin, LSD and MDMA, as Schedule 1 substances. This classification is reserved for drugs that are considered to have no medicinal value and a high potential for abuse. Consequently, the possession, distribution or use of psychedelics for any purpose is illegal, with serious legal penalties attached to having them.
One of the concerns surrounding psychedelic use is the potential for misuse or negative/challenging experiences, such as “bad trips”.
However, when administered in a controlled, clinical setting under the supervision of trained professionals, the risks are significantly reduced.
While profound experiences have been linked to therapeutic benefit for some participants in clinical trials, these states can be disruptive and distressing without sufficient aftercare and support. It is essential that support to safely integrate these experiences into the person’s life are built into models of care.
Many people are already seeking these substances through illegal underground channels such as facilitated experiences or retreats.
Anecdotal reports regarding safety and quality of care are mixed, with no ethical standards or codes of conduct for those operating these services.
Even under clinical trial conditions, there are lessons to be learnt.
The US Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for the treatment of PTSD, citing concerns related to expectancy effects, blinding, the lack of long-lasting benefits, together with poor standardisation of psychotherapy and safety data not being adequately recorded.
While the research landscape is complex, the regulation of psychedelics in clinical settings is restricted in Ireland.
There were also ethical concerns about misconduct between therapists and participants.
Notwithstanding the FDA’s decision, in certain jurisdictions in the US, and in Australia, psilocybin and MDMA therapies have already been approved as treatments. This allows authorised psychiatrists to prescribe psilocybin and MDMA to patients diagnosed with treatment-resistant depression and treatment-resistant PTSD, respectively, in approved centres, but outside of a clinical trial setting.
While the psychedelic research landscape is highly complex, it is clear that the regulation of psychedelics in clinical settings remains heavily restricted in Ireland and not aligned with the latest scientific evidence.
Easing the regulatory constraints would facilitate the advance of the scientific evidence underpinning psychedelics and psychedelic therapy.
The development of a Psychedelic Science Research Centre, embedded within the public health system in Ireland, perhaps using a hub and spoke model, could optimise existing resources, provide standardisation, quality and accountability, accessibility (particularly for those in marginalised communities), together with an opportunity to facilitate the collection of long-term data on outcomes.
This would hopefully shape the eventual integration of psychedelic therapy into the public health system for the benefit of patients in Ireland.
This article was originally published in the Irish Independent on Friday 25th October 2024 to coincide with Ireland’s first psychedelic research conference hosted by Trinity College Dublin on the same date.
The heading of the original article was: “John R Kelly: Psychedelic therapy has been found to improve numerous mental health conditions – Ireland needs to loosen regulation on its study”. It was amended for the purpose of brevity here.
Dr Kelly is associate professor of Psychiatry at the School of Medicine and the Trinity College Institute of Neuroscience.
