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Psychedelics for frontline workers, palliative care and eating disorders

Novamind is researching psychedelics and ketamine to help transform healthcare.

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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.

See also  FDA authorises psychedelic therapy trial for COVID frontline workers

“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.

See also  Beckley Psytech collaboration to develop next-gen psychedelic medicines

“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.

See also  Measuring ketamine’s effects with neuroimaging technology

“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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Study identifies MDMA variants that could make therapy safer

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Study identifies MDMA variants that could make therapy safer

A new study from MedUni Vienna has identified three new variants of MDMA as promising alternatives for safer use in a controlled psychotherapeutic setting.

The recent blow to MDMA therapy from the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) has put a dampener on many people’s hopes that the treatment would be approved this August.

While that still may happen, one of the major concerns of the advisory body was the compound’s safety data, and the PDAC has advised that Lykos has not collected enough safety data on the molecule in its trials so far.

See also  FDA MDMA therapy advice may be a setback, but it is not the end of the road

Despite this setback in the US, countries such as Canada and Australia have increased legal access to MDMA-assisted psychotherapy for PTSD in recent years.

However, there are concerns about the safety profile of the drug due to its side effects such as tachycardia, high blood pressure, and liver and nerve damage despite promising studies.

Safer alternatives

Now, published in the Journal of Neurochemistry, an international research team led by Harald Sitte at MedUni Vienna’s Center for Physiology and Pharmacology has identified three new variants of MDMA as promising alternatives for safer use.

According to the team, the variants – ODMA, TDMA and SeDMA – have been developed to retain the positive effects of MDMA while reducing negative effects.

The studies suggest that the variants impact structures in the brain such as serotonin and dopamine in a similar way to MDMA, but unlike MDMA, they have lower activity at certain serotonin receptors.

Study lead Harald Sitte stated: “This allows the conclusion that both the acute and long-term side effects of ODMA, TDMA and SeDMA may be lower than those of the conventional substance.”

“Since the MDMA analogues also have a weaker interaction with certain transport proteins in the body that are responsible for the absorption and excretion of drugs, the risk of interactions with other drugs could also be reduced,” added first author, Ana Sofia Alberto-Silva.

Sitte continued: “Our experimental results showed that the new variants can retain the therapeutic potential of the conventional substance, but are likely to cause fewer side effects.

“This could advance the controlled use of psychoactive substances in neuropsychiatric illness.”

The authors wrote: “Our findings suggest that these new MDMA bioisosteres might constitute appealing therapeutic alternatives to MDMA, sparing the primary pharmacological activity at hSERT, hDAT, and hNET, but displaying a reduced activity at 5-HT2A/2B/2C receptors and alternative hepatic metabolism. Whether these MDMA bioisosteres may pose lower risk alternatives to the clinically re-emerging MDMA warrants further studies.”

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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).

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.”

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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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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