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How psychedelics could help those living with alcohol use disorders

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Psychedelic retreats are mushrooming

Alcohol use disorders (AUD) are estimated to affect around 237 million people across the globe, with 3 million deaths each year attributed to the harmful use of alcohol.

Despite this prevalence, there is a lack of effective treatment options and relapse rates remain high, but hope is on the horizon in the form of clinical research that is starting to show the therapeutic potential of psychedelic compounds for problematic drinking.

AUD affects millions of people around the world. In fact, approximately one in every 20 deaths globally are in some way related to alcohol, be it through disease, injury, or accident. There are over 600,000 dependent drinkers in England alone, and, in the US, roughly a third of people meet the criteria for AUD on a lifetime basis. Sadly though, only 21.9% of patients across the globe receive treatment for AUD and many struggle with relapse. 

Why is this? Well, put simply, the treatment landscape for AUD is incredibly complex and there are many barriers throughout the treatment pipeline. Whether it’s the mental barrier of actually wanting to stop drinking, physical dependence, fear of withdrawal symptoms, the lack of awareness of what support is actually available, or the cost of treatment, it can be difficult for people living with AUD to know what to do.  

And even if they are screened by a healthcare professional, the treatments available may not be effective for them. There may be undesired side effects and up to 70% of people taking pharmacological treatments for AUD find no positive outcomes. This means there is a huge unmet need for better, more effective and more accessible treatments – and this is where psychedelics come in. 

See also  Optimi Health to enter Australia with psilocybin and MDMA agreement

How psychedelics are offering hope to those that struggle most

Thanks to a growing body of research, psychedelics have become a new medicine of interest for those looking to ease the burden substance use disorders have on individuals, families and healthcare systems. Psychedelics are believed to work by inducing a ‘window of neuroplasticity’ in the brain, which opens up the possibility for new behaviours or patterns of thinking to be developed. It is this ability that makes psychedelics so interesting in the case of treating conditions like AUD where addiction-related habits and emotions play a huge part.

The science is promising. In the U.S, a recent study led by the New York University Grossman School of Medicine showed that psilocybin treatment improved drinking outcomes in patients with AUD relative to outcomes observed with a placebo medication. Specifically, the study found that two doses of psilocybin, when combined with psychotherapy, reduced heavy drinking by 83%. Another study found that ibogaine, a psychedelic derived from the roots of a West African shrub, when used in conjunction with psychotherapy, could increase periods of abstinence in those with alcohol and other substance addictions. 

At Beckley Psytech, we’re exploring the potential of our synthetic formulation of 5-MeO-DMT, BPL-003, for AUD in a Phase IIa study. Phase I healthy volunteer data has already shown that BPL-003 is well-tolerated and can reliably induce profound subjective experiences (a correlate of positive clinical outcomes) with a rapid onset and timely offset of perceptual effects. The Phase IIa study will explore the safety, efficacy and pharmacokinetics of BPL-003 alongside an abstinence-oriented cognitive behavioural programme in patients diagnosed with AUD. Topline results are expected later this year.

See also  Nearly half of Americans support psychedelics as mental health treatments

Collaboration is critical

It is, of course, still early days but the science seems to be indicating that psychedelics, when administered in the right context and with the right support, can help those who are suffering from a range of mental health conditions. With clinical studies progressing, and approval for other psychedelic treatments expected in the next few years, now is the time to develop the infrastructure that will allow us to actually deliver these interventions to people living with AUD. This involves us all: patients, regulators, investors, healthcare professionals and drug developers.

At Beckley Psytech, we are always looking to hear from others in the space so please head over to www.beckleypsytech.com to learn more about our work in AUD and how to get in touch.

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Medicinal

MDMA for PTSD receives priority review for New Drug Application

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Photo by iStrfry , Marcus on Unsplash

Lykos Therapeutics, formerly MAPS Public Benefit Corporation, has announced it has received FDA acceptance and priority review for a New Drug Application (NDA) concerning its MDMA-assisted therapy for PTSD.

The FDA has accepted Lykos’s NDA for MDMA capsules used in combination with psychological intervention. This intervention includes psychotherapy and other supportive services provided by a qualified healthcare provider for individuals with PTSD. 

Lykos has stated that the FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. Current statistics show that 89% of applications that meet their PDUFA deadline are approved. If this application is approved, it would make this the first MDMA-assisted therapy and psychedelic-assisted therapy.

In a press statement, Amy Emerson, chief executive officer of Lykos Therapeutics, commented: “Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD.

“We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

The NDA submission was supported by results from several studies on the therapy, including two Phase 3 studies that looked at the efficacy and safety of the therapy. Both of these studies met their primary endpoints, which were a change in PTSD symptom severity and an improvement in functional impairment associated with PTSD. 

While no serious adverse events were reported in the MDMA group in either study, Lykos highlights that the safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.

See also  Health Canada approves Phase 2 take-home psilocybin trial for anxiety

The news has been welcomed across the pond by European campaign groups advocating for access to psychedelic-assisted therapy. 

In a press statement, campaign group PAREA commented: “Innovation in mental health has stagnated for decades. In the past three years, Europe has approved only one new psychiatric treatment, compared to 68 in oncology. 

“While the U.S. is on the brink of approving the first psychedelic-assisted therapy, Europe significantly lags behind. This is primarily because the current incentives and rewards for companies to conduct large-scale pivotal trials on psychedelics are insufficient in Europe, highlighting the need for enhanced support and incentives to advance novel mental health treatments.”

While the US makes strides in advancing psychedelic healthcare, Europe is now beginning to take note of this scientific development, with the European Medicines Agency (EMA) set to hold a multi-stakeholder workshop on medical psychedelics in April 2024.

The workshop aims to establish regulatory guidelines for the development and therapeutic use of psychedelic substances in Europe.

The continent also made a recent historic advancement in the field of psychedelic research. In January 2024, the European Union announced €6.5 million in funding for research into psychedelic therapy as part of its Horizon Europe programme. 

The funding has been awarded to a consortium of 19 partners from nine different European countries for a clinical trial – the PsyPal trial – which will study psilocybin-assisted psychotherapy for psychological and existential distress in people who are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) or atypical Parkinson’s disease (APD). 

See also  Optimi Health to enter Australia with psilocybin and MDMA agreement

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Doctors warn against potentially harmful psychedelic “trip killers”

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Doctors have raised a warning against so-called “trip killers” that are used to end challenging psychedelic experiences on compounds such as LSD or psilocybin.

The doctors have published the warning in a letter in the Emergency Medicine Journal. In the letter, an analysis of relevant Reddit threads is provided that show drugs such as benzodiazepines and antipsychotics recommended to help end these challenging psychedelic experiences. However, the doctors emphasise that these recommendations rarely include information about potential side effects.

A total of 128 Reddit threads created were discovered that were created between 2015 and 2023, yielding a total of 709 posts. With 440 recommendations, amounting to nearly half – 46% – of all the ‘trip-killers’ mentioned in posts, were various benzodiazepines, followed by several different antipsychotics at 171%.

See also  Mixing psychedelics with lithium poses significant risk of seizures

The team found that one in 10 recommendations were for antidepressants, while one in 20 were for alcohol. Opioids, antihistamines, herbal remedies, such as camomile and valerian, and prescribed sleeping pills, attracted 3% each, with cannabis and cannabidiol at 2%.

Trip-killers were mostly discussed in reference to countering the effects of LSD (235 recommendations), magic mushrooms (143), and MDMA (21). Only 58 posts mentioned potentially harmful side effects.

The authors write: “The popularity of benzodiazepines raises concerns. Benzodiazepines are addictive and have been repeatedly implicated in overdose deaths. 

“The doses described on Reddit risk over-sedation, hypotension [low blood pressure], and respiratory depression [stopping breathing or shallow breathing].”

Doses of one of the recommended antipsychotics, quetiapine, were also high the authors note, with only a few posts differentiating between fast and slower release formulations.

“Information on trip-killers isn’t available through drug advice services, despite the probable risks they pose,” highlight the authors.

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Integrating metaphysics into psychedelic therapy

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Integrating metaphysics into psychedelic therapy

Dr Peter Sjöstedt-Hughes, Lecturer at Exeter University, has proposed incorporating metaphysical philosophy into psychedelic therapy to help improve therapeutic outcomes.

Sjöstedt-Hughes suggests that psychedelic therapy may gain more advantage by extending its scope into metaphysics, helping patients better integrate and understand psychedelic-induced metaphysical experiences.

Such improved outcomes may be seen if patients undergoing this therapy “are provided with an optional, additional, and intelligible schema and discussion of metaphysical options at the integrative phase of the therapy.” 

See also  Study explores relationship between psychedelics and consciousness

In the paper, Sjöstedt-Hughes puts forward this schema as the “Metaphysics Matrix” and an accompanying “Metaphysics Matrix Questionnaire (MMQ)” which can be utilised by therapists and researchers as a tool for the quantitative measurement of a psychedelic experience.

The paper ‘On the need for metaphysics in psychedelic therapy and research’ has been published in Frontiers in Psychology.

What is metaphysics?

While mysticism deals with understanding the universe through direct experience, such as revelation, metaphysics is a branch of philosophy that deals with understanding the fundamental nature of reality through logic/argument.

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Sjöstedt-Hughes writes that “metaphysics is not mysticism” but there is overlap: “[…] metaphysics is broader and its positions can be logically deliberated — as such metaphysics can encompass mystical experiences induced by psychedelic intake yet metaphysics can also ground those experiences in a manner that can be more intelligible, comprehensive, viable, and acceptable to participants than that which the framework of mysticism alone can offer.”  

The Metaphysics Matrix

A number of clinical trials investigating psychedelic-assisted psychotherapy for the treatment of mental health conditions, such as anxiety and depression, report that participants who undergo a “mystical experience” during a psychedelic session often have higher levels of sustained therapeutic outcomes.

In clinical trials, mystical experiences are measured by different scales including the Mystical Experience Questionnaire (MEQ), the Hood Mysticism Scale (HMS), the Hallucinogen Rating Scale (HRS), the Five Dimensions Altered State of Consciousness Questionnaires (5D-ASC) and Eleven Dimensions Altered State of Consciousness Questionnaires (11D-ASC).

Sjöstedt-Hughes writes: “Data derived in this manner is obviously limited and abstract not only because psychedelic experience need not be “mystical,” but also because the definition of “mystical” could be expanded to include other criteria [

“With regard to psychedelic-assisted psychotherapy […] speaking about mystical experience per se will not be sufficient to provide a meaningful explanation of the significance of such experience to a person, for the simple reason that mystical experience is the phenomenon to be explained — mystical experience is the explanandum rather than the explanation. 

“It is metaphysics that is the means of explanation, the explanans of the mystical explanandum.”

The Metaphysics Matrix has been designed to provide a “menu” of metaphysical options that may help people to “frame, make sense of, and give significance to, their experiences”, and would be another tool in the belt of therapists to better understand these experiences.

Image provided by Dr Peter Sjöstedt-Hughes.

Such experiences could be understood through metaphysical systems such as Neutral Monism, Pantheism, Panpsychism, Animism, Substance Dualism, and Idealism, says Sjöstedt-Hughes. 

Some examples provided include the common experience of the Universe being God – which can be understood in the context of Pantheism – or of all matter having a basic form of sentience – such as plants having a basic drive or process – which can be understood in the context of Panpsychism. 

Image provided by Dr Peter Sjöstedt-Hughes.

Additionally, enabling people who have had these experiences to understand them within these frameworks may make them less likely to dismiss the experiences as delusional, says Sjöstedt-Hughes.

“ […] Relatedly, that the worldview hitherto adopted by the participant is but one metaphysical position amongst others,” he writes. 

Sjöstedt-Hughes commented: “This is a conjecture that hasn’t been tested but can be tested – offering a patient an additional and optional discussion in the integrative phase of psychedelic-assisted psychotherapy. 

“Giving them this Metaphysics Menu for integration may extend the long-term benefits of psychedelic therapy and beyond because there’s a number of studies that seem to show that certain peak psychedelic experiences have the longest and most beneficial health outputs results.

“If in the integrative phase [of therapy] one looks at that experience and starts to frame it intelligibly, then the conjecture is that the participant will not in a few weeks after that, think it must have been a delusion – they will say that we don’t know what reality is. 

“Therefore, we can’t dismiss something as a delusion necessarily. By doing that it might extend the significance of that experience for the person.

“When we use Mysticism Scales, by definition, mystery can’t explain itself. Metaphysics, however, incorporates those experiences and offers an explanation to what they mean. For example, the relation between oneself and the universe.”

Sjöstedt-Hughes points out that in practice, one of the immediate issues is the practical issue of implementation of Metaphysics Integration, suggesting this could be supported through resources such as a handbook or practitioner training.

He further concludes the integration would need to be “further bridged by the therapist to the participant’s life, concerns, values, aims, and outlook.”

The Metaphysics Schema is already being utilised in studies taking place at Ohio State University, US, and Exeter University, UK.

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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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