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Psychedelics for frontline workers, palliative care and eating disorders

Novamind is researching psychedelics and ketamine to help transform healthcare.



Psychedelics for frontline workers, palliative care and eating disorders

Psychedelic-assisted psychotherapy is being investigated by Novamind to help people with difficult-to-treat indications and who are historically underserved.

Novamind, which describes itself as sitting at the intersection of medicine, mental health and spirituality, is delivering its psychedelic-assisted psychotherapy through three programmes. 

The company’s palliative programme is combining psychotherapy with workshops and multi-day immersive retreats, and its second programme, a clinical pilot, explores, ketamine-assisted psychotherapy for frontline workers. Called Frontline KAP, the programme has designated a psychedelic therapy protocol for a total of 40 frontline healthcare workers that have been impacted by stress and trauma from working on the COVID-19 pandemic.

It has also created the Emotion-Focused Ketamine-Assisted Psychotherapy (EF-KAP) for eating disorders. EF-KAP aims to support the emotional health of patients with eating disorders while also leveraging the healing power of a supporting partner. The company says the psychotherapy protocol aims to help individuals learn to process and gain mastery of their emotions. More recently the company has launched a psychedelic clinical trial for opioid use disorder.

Novamind is led by Dr Paul Thielking, certified in psychiatry, hospice, palliative and integrative medicine, and chief medical officer, Dr Reid Robison, who spoke to Psychedelic Health about the company’s clinical research.

Robison began his career over ten years ago and since has become increasingly discouraged by existing treatments for patients. Setting out to find and implement new treatments – Robison discovered ketamine, which was being researched in psychiatry for treatment-resistant depression.

“I did my first study of ketamine in 2011 and was just blown away by not only the response rate but by the rapid response,” said Robison. “In recent years, I’ve been increasingly interested in the psychedelic experience and the psychotherapy that we can pair with it.”

With a network of clinics, research sites and specialist expertise in psychedelic medicine, Dr Robison says Novamind is working hard to elevate the standard of mental healthcare through the introduction of new, evidence-based treatment options.

Psychedelics for frontline workers, palliative care and eating disorders

Psychedelics in palliative care

Novamind believes psychedelics could be beneficial for a number of different areas of mental health – one of those being palliative care, says Robison.

“For palliative care, those suffering from serious conditions can have co-occurring mental health concerns,” says Robison. “With the addition of our chief scientific officer Dr Paul Thielking’s special expertise in palliative medicine and psychedelics, we’ve launched this new programme to provide a comprehensive treatment programme to individuals with all serious medical and mental health concerns – using psychedelic medicine whenever appropriate.”

The company will be starting with ketamine and then expanding into other areas as they become available to research, and later on clinically if approved. Novamind’s programme consists of workshops and immersive retreats that emphasise the importance of group therapy.

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“This is to add important and useful skills to the equation,” says Robison. “Such as mindfulness-based stress reduction, and other mindfulness interventions, and integration, group and individual psychotherapy, psychotherapeutic integration for any psychedelic medicine experiences that may be part of the programme, along with other focused workshops around integrative health models treating the whole individual.

“We are really big fans of the group model, when appropriate, which are part of our treatment programme for a number of reasons. First and foremost is the power of community and the healing potential of groups because for many conditions, just by participating in a group with others who share a similar struggle, there can be a lot of relief that comes from knowing that you’re not alone in this. 

“There’s also some economic benefits to groups – opening up access and reducing costs for individuals who might not otherwise be able to access therapeutic options.”

The company has now been selected to carry out a Phase II clinical trial, which has received FDA approval, for people with a life-threatening illness by the Ketamine Research Foundation. 

Ketamine for frontline workers

Frontline work is an intensely demanding role – an occupation that comes with emotional stresses and trauma. The past two years have seen this stress compounded by working in the global healthcare crisis of COVID-19.

One study has highlighted that during the pandemic, 49 per cent of frontline workers experienced burnout. Another systematic review of the studies exploring the impact of COVID-19 on healthcare workers highlighted that the pandemic posed an increased risk of “acquiring trauma or stress-related disorders, depression and anxiety”, and that the fear of becoming infected was at the forefront of mental health challenges for workers, with perceived stigma from family and society leading to increased stress and isolation. 

Novamind’s programme for frontline workers aims to help them with the mental health struggles they have been faced with throughout the pandemic.

Robison commented: “This is really a really meaningful programme for me because I think as healthcare workers, we felt firsthand for years, the stress and the risk of burnout that comes along with these caring professions. The pandemic has been extremely stressful, difficult and even traumatic for some individuals. 

“One silver lining that’s come from it in my opinion, is a renewed focus on our mental health or an appreciation of the importance of taking care of ourselves and others. The statistics around burnout are quite striking and the stress and mental health struggles that can come from workplace stress.

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“We have designed a programme with our friend and collaborator, Dr Scott Shannon of Colorado’s Wholeness Centre, that we’re offering to healthcare workers with stress burnout or even trauma from their work, often on the frontlines of the pandemic.”

The programme consists of six sessions with three ketamine doses, along with a group therapy protocol. 

“t’s a clinical pilot programme that has been really rewarding to participate in and really well appreciated by the participants,” said Robison. “We’re seeing in the data not only reductions in depression, anxiety and burnout measures, but also big increases in resilience.

“This fills an important need, in my opinion, because this puts healthcare workers with peers in the space to help them really feel that they’re not alone and that they can learn from each other and participate in this programme together. There has traditionally been an unfortunate stigma preventing people in healthcare professionals from accessing care due to fear of there being negative consequences on their jobs. 

“One of our aims is to try and address some of those difficulties or barriers of access.”

Novamind has now advanced its clinical programme for frontline workers, with the final cohort of  patients expecting to begin treatment in March 2022.

Ketamine therapy for eating disorders

Novamind has developed a ketamine assisted psychotherapy protocol for anorexia nervosa along with other eating disorders – EF-KAP. There are currently 30 million people in the US living with an eating disorder, according to the National Association of Anorexia Nervosa and Associated Disorders. Of those with anorexia nervosa, 5 to 10 per cent die within 10 years of having the condition.

“There’s a lot of suffering related to disordered eating behaviour patterns and body image distress,” says Robison. 

Robison and his colleague Dr Adele Lafrance both worked on the MAPS MDMA study for eating disorders, and the pair have drawn from the worlds of emotion focussed therapy to design Novamind’s ketamine assisted psychotherapy protocol for anorexia. Emotion focussed therapy gives people the tools they need to navigate life, says Robison. 

“We teach clients how to tune into their emotions, how to process them, how they might be related to mental health conditions and how they can be used for healing. We review these early on and we practice them and revisit them.

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“In the ketamine assisted psychotherapy protocol, which is guided by these principles of emotion focused therapy, we use ketamine as the catalyst to move towards emotional experiences instead of away from them, instead of disconnecting from them. 

“In eating disorders especially there is a common theme for many of us, disconnecting from emotions with certain behaviours. There is something called alexithymia, which is a disconnect from emotions, and that is seen in a significant way in certain eating disorders.”

Robison highlights that historically, eating disorders have been very difficult to treat, with anorexia being considered one of the most serious and deadly mental health conditions with the highest mortality rate from both a combination of medical and mental health consequences.

“We really feel that this therapeutic modality is best integrated with existing mental health treatments,” says Robison. “So, we work closely with other members of a treatment team wherever they may be, including a dietitian, a psychiatrist, primary care providers and psychotherapists to bring in this programme.”

For someone who is living with a condition such as anorexia, ketamine therapy might be perceived to have strong implications for the health of the patient.

Robison said: “There’s some growing evidence that certain medicines like antidepressants, for example, might not work as well when significantly malnourished – we don’t know that about ketamine yet. 

“Ketamine is extremely safe compared to other medicines because of how well known it is to the medical field and anaesthesia, and how it doesn’t slow down breathing. Ketamine does have risks to consider of course, and we do for that reason implement careful medical and psychiatric screening as part of the process. We also make sure there are medical parameters in place to guide us in terms of who is appropriate for it and how to best use it. 

“But we have been able to implement this protocol in individuals with even severe anorexia nervosa in our initial open-label clinical trial with good preliminary safety and feasibility outcomes.”

Robison highlights it is important to do more research and that with ketamine-assisted psychotherapy being a nascent field, there are protocols and evidence-based guidance that are needed. 

Novamind’s open-label trial so far, adds preliminary evidence to what Robison says is an important new approach to care for people with eating disorders.

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Mapping the effects of ketamine on the brain



Mapping the effects of ketamine on the brain

A new study has mapped the effects of ketamine on the brain, finding that repeated use over extended periods creates widespread structural changes in the brain’s dopamine system.

The study found that repeated ketamine exposure leads to a decrease in dopamine neurons in midbrain regions linked to regulating mood. They also revealed an increase in dopamine neurons in the hypothalamus, which regulates the body’s basic functions like metabolism and homeostasis.

A former finding that ketamine decreases dopamine in the midbrain, may indicate why long-term abuse of ketamine could cause users to exhibit similar symptoms to people with schizophrenia. 

The researchers suggest that their new finding that ketamine increases dopamine in the parts of the brain that regulate metabolism, published in Cell Reports, may help explain why it shows promise in treating eating disorders.

They suggest this strengthens the case for developing ketamine therapies that target specific areas of the brain, rather than administering doses that wash the entire brain in ketamine.

Raju Tomer, the senior author of the paper, stated: “Instead of bathing the entire brain in ketamine, as most therapies now do, our whole-brain mapping data indicates that a safer approach would be to target specific parts of the brain with it, so as to minimise unintended effects on other dopamine regions of the brain.”

Tracking detailed data

The researchers tracked highly detailed data that enabled them to track how ketamine affects dopamine networks across the brain. 

The insight revealed that ketamine reduced the density of dopamine axons (nerve fibers) in the areas of the brain responsible for hearing and vision, while increasing dopamine axons in the brain’s cognitive centers, which may help explain the dissociative behavioral effects observed in individuals exposed to ketamine.

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Malika Datta, a co-author of the paper, added: “The restructuring of the brain’s dopamine system that we see after repeated ketamine use may be linked to cognitive behavioral changes over time.”

Most studies of ketamine’s effects on the brain to-date have looked at the effects of acute exposure – how one dose affects the brain in the immediate term. 

For this study, researchers examined repeated daily exposure over the course of up to ten days. Statistically significant alterations to the brain’s dopamine makeup were only measurably detectable after ten days of daily ketamine use. 

The researchers also assessed the effects of repeated exposure to the drug at two doses, one dose analogous to the dose used to model depression treatment in mice, and another closer to the dose that induces anesthesia. The drug’s effects on dopamine system were visible at both doses.

“The study is charting a new technological frontier in how to conduct high-resolution studies of the entire brain,” said Yannan Chen, paper co-author. 

It is the first successful attempt to map changes induced by chronic ketamine exposure at what is known as “sub-cellular resolution,” in other words, down to the level of seeing ketamine’s effects on parts of individual cells.

Most sub-cellular studies of ketamine’s effects conducted to date have been hypothesis-driven investigations of one area of the brain that researchers have targeted because they believed that it might play an important role in how the brain metabolises the drug. 

This study is the first sub-cellular study to examine the entire brain without first forming such a hypothesis.

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Bradley Miller, a Columbia psychiatrist and neuroscientist who focuses on depression, said: “Ketamine rapidly resolves depression in many patients with treatment-resistant depression, and it is being investigated for longer-term use to prevent the relapse of depression. 

“This study reveals how ketamine rewires the brain with repeated use. This is an essential step for developing targeted treatments that effectively treat depression without some of the unwanted side effects of ketamine.”

“This study gives us a deeper brain-wide perspective of how ketamine functions that we hope will contribute to improved uses of this highly promising drug in various clinical settings as well as help minimise its recreational abuse. More broadly, the study demonstrates that the same type of neurons located in different brain regions can be affected differently by the same drug,” added Tomer.

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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.”

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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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Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research



Clerkenwell Health calls for volunteers to support groundbreaking psychedelic research

Mental health research provider Clerkenwell Health is calling for volunteers to join its groundbreaking clinical trials that will research whether psychedelics can provide effective treatments for complex mental health conditions.

Clerkenwell is seeking a diverse group of volunteers from across the UK between 18 and 65 years old to take part in the trials if they suffer from a relevant condition. 

The trials, which will be conducted at Clerkenwell Health’s purpose-built facility near Harley Street in London, are being run in partnership with a number of world-leading drug developers to test whether psychedelic drugs – often combined with talking therapy – can offer a new approach to treating a variety of mental health illnesses.

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Clerkenwell Health is seeking volunteers for trials that look to find cures for a range of conditions, including PTSD, depression, alcohol use disorder and anorexia. 

Many of the conditions have few successful treatment options and Clerkenwell’s innovative methods of combining psychedelics with therapy aim to to treat these problems more holistically, providing long-term quality of life for patients.

Chief Scientific Officer at Clerkenwell Health, Dr Henry Fisher, said: “With the current system for treating mental health disorders simply not working, we’re calling for patients to help identify the next wave of treatments. 

“These have the potential to be groundbreaking for the millions of people across the UK who are affected by poor mental health.

“The status quo for mental health treatment has not only resulted in patients experiencing debilitating side-effects, huge waiting lists and high relapse rates, but is costly, complicated and broadly ineffective. 

“By participating in upcoming clinical trials, patients have an opportunity to make a valuable contribution to growing research which will support the development of the next generation treatments for mental health conditions.”

According to MIND, approximately 1 in 4 people in the UK will be affected by a mental health condition each year and with a significant rise in people contacting mental health services in recent years, there has never been a more desperate need to identify new and innovative treatments.

Given the challenges facing the country’s health service and with mental health challenges on the rise, the search for volunteers to test effective treatments has never been more pressing. 

Clerkenwell has stated, in this regard, that it has gone national with its search for volunteers in an effort to deliver medical breakthroughs in mental health akin to the Polio clinical trials in the 20th Century.

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