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First professional practice guidelines for psychedelic therapy published



First professional practice guidelines for psychedelic therapy published

The first-ever Professional Practice Guidelines for psychedelic therapy in the US have been published by the American Psychedelic Practitioners Association (APPA) and BrainFutures.

APPA and BrainFutures have established the guidelines with the aim of setting a benchmark for practitioners in psychedelic therapy. 

With increasing clinical research showing positive results from psychedelic therapies as treatments for conditions such as post-traumatic stress disorder (PTSD) and treatment-resistant depression, such guidelines are vital if these therapies are to gain regulatory approval.

See also  World first study to explore psilocybin for gambling addiction

The guidelines have been written by a working group of experts from multiple disciplines, and have been informed by more than two dozen members of APPA, who contributed perspectives on justice, equity, diversity, and inclusion; the real-world practice of psychedelic-assisted therapy; and psychedelic use in indigenous and other settings. 

“These are the most important first steps because they now set up the context for clinicians to use these particular compounds and medicines in a therapeutic way,” APPA Executive Director, Stephen Xenakis, told Psychedelic Health.

The guidelines cover topics such as consent, ethics, patient screening, preparation and safety, integration and more. 

“We were able to convene well over a year, experts who had been clinicians, researchers, consultants and advisors in the field, to pull from them the best ideas of what they knew about these practices,” added Xenakis.

“Also what they knew that had been used historically. These medicines have been around for many, many decades, and the concepts that really shape how you do the practice, have probably been around since the late 19th century. To some people who are much better scholars, they’ve been around for 1000s of years. 

“So there’s a long history of practice with these compounds, and the therapy, the healing that goes with them.”

Advancing innovative mental healthcare

According to the CDC, more than one in five US live with a mental illness, with young adults aged 18 to 25 years having the highest prevalence according to the National Institute of Mental Health.

Xenakis highlights that, for decades, the medical system has been disease centred, where a person is given a diagnosis which is specifically treated.

“That really was very useful – it did offer all of these years that particularly as we’ve developed new drugs and treatments, that’s been helpful,” said Xenakis. “But in fact, we now know that when it comes to mental health and brain conditions, there’s much more to those patients – the whole is much more than the sum of the parts.

“The ideas that are talked about our patient-centred care, what does the patient really come with? And what does the patient need? And how do you do set and setting and you use the drugs as the means to open up what is most important in the therapy in the interaction of the traders, the healers? And the patients? So that’s a big fundamental concept here, and most important, because it’s a game changer.”

Regulatory approval

The FDA approval of psychedelic-assisted therapies using MDMA and psilocybin has been anticipated for 2024, but to ensure the rollout, clinical practice, ethical and billing guidelines are essential.

In lieu of any potential approvals, APPA agreed this consensus-based guideline development is necessary to speed the adoption of psychedelic treatments into the US healthcare system and ensure access for all who could benefit.

“It’s very important for our governmental agencies and our payers as well. So they know that this is a more standardised way of treatment,” said Xenakis.

“It’s not just something that’s happened in a community over years in a way that’s been more free-range, but now it’s really formalised. So, it’s vitally important that we start with these professional practice guidelines.

“The governmental agencies can be reassured that very thoughtful, professional practitioners are looking at providing these treatments in a very methodical way. That – I think – can accelerate making them available to the people who need it. 

“Access and equity are very, very important. We not only want to make sure that we’re doing the right thing that’s fundamental here – do no harm – but that the people that need this therapy are getting it.

“We have in this country, and also occurs in Europe, a mental health crisis. We have too many suicides. We have too many opioid overdoses. We have huge consequences and ripple effects of COVID and loneliness, and people are finding that their health and mental health is interfering with their work, with being able to enjoy their lives, with their relationships with their families. 

“It’s vitally important for us to make these treatments and therapies accessible across the country and not only to people who can pay.

“This is a game changer. We’re at an inflection point, not only in our societies, and perhaps in our politics, but also health care, and now we’re bringing a particular capability at this time that can shift things significantly.”

The guidelines will be subject to change in the coming years as more research and real-world data become available, expiring two years from the date of publication.

APPA says the next steps will be to develop clinical practice guidelines, accreditation standards and ethical guidelines by 2024.

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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.

See also  Psychedelics for frontline workers, palliative care and eating disorders

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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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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Short Wave Pharma: innovating eating disorder care with psychedelics



Short Wave Pharma: innovating eating disorder care psychedelics

Psychedelic Health speaks to Short Wave Pharma CEO Rivki Stern about the company’s plans to innovate eating disorder care through psychedelics and its recent acquisition by Psych Capital.

Short Wave Pharma was recently acquired by global investment firm Psych Capital. The companies are on a mission to transform mental health care, focusing on innovative approaches and treatments, including psychedelics, which are increasingly gaining acceptability as clinical research results accumulate.

Short Wave Pharma’s clinical programmes are particularly focused on Anorexia nervosa – a complex mental health condition with one of the highest fatality rates. Despite the condition being associated with high rates of suicide, it is a hugely underserved area of mental health, with no FDA-approved pharmacological drug, and a high rate of chronicity. 

See also  Psych Capital completes acquisition of Short Wave Pharma

The company has developed a novel delivery method and drug combination specifically designed to address the requirements of this vulnerable population. Short Wave focuses on methods of delivery that will be effective for Anorexia, which is a metabolic disease as well as a mental health condition. Its unique buccal film delivery method is intended to affect the brain while bypassing the liver and gut degradation through mucoadhesive absorption.

“Our goal is to alleviate, solve, and treat mental health conditions. It’s a dire need in our global society, and it’s constantly on the rise,” commented Stern. “Eating disorders are a very good example of that and we have seen a very alarming growth since COVID. 

“What drew our attention to psychedelics is that they have the potential to address very complex mental health diseases and have been designated by FDA as breakthrough medicine for life-threatening conditions.

“Because there are no current solutions, we must harness very innovative approaches and potential solutions. That’s why we started working with psychedelics which may be difficult because they are not regulated, but we don’t shy away from challenges.”

The company’s drug is based on psilocybin and another API which together utilise an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain. 

The delivery method is sensitive to the patients’ needs – who may not want to swallow or be injected – and is known for its high bioavailability. 

“By mucosal absorption, we are speeding the onset of the medicine and amplifying the impact which will help tackle the patients’ metabolic challenges and improve acceptance,” says Stern. 

The drug product and delivery method are currently in preparation for Phase 1 clinical studies, and in its current preclinical studies, the company is validating its delivery and expanded mechanisms of action. So far, initial safety results are positive, with a further, more in-depth toxicity study taking place. 

Psych Capital – which is a public investment and awareness platform for mental health, and has a portfolio of innovative companies – has supported Short Wave Pharma’s IP-driven approach to eating disorder care through its recent acquisition of the company.

Short Wave and Psych Capital say they are aligned in their missions to innovate mental healthcare and deliver transformative care in areas of high unmet need.

Stern commented: “We all share a passion for innovation and together have decades of experience in evaluating investments as well as scaling up R&D projects and start-ups in life sciences. 

“We have a shared commitment to alleviate the suffering from mental health. Every one of us has experienced the frustration and challenges of dealing with mental health issues.

“Together, we’re going to put this commitment into action, by bringing forth innovative solutions and developments and getting them through the first stages of development, from discovery through to early phases of clinical study. 

“With psychedelics components, this is extra challenging because of their status as scheduled drugs within a still evolving regulatory framework, which adds uncertainty to the drug development process. 

“Short Wave Pharma has operational expertise in early-stage drug development which will bring extra value to the group’s projects as they develop through our funnel and grow into promising candidates for mental healthcare.  

“We want to identify the gems, guide them through clinical development, and create the right network to attract the right partners for further development and commercialisation.”

Short Wave Pharma is planning to enter its treatment into clinical studies in 2024.

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