Connect with us

Research

Psychedelics for frontline workers, palliative care and eating disorders

Novamind is researching psychedelics and ketamine to help transform healthcare.

Published

on

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  Landmark psilocybin trial begins with dosing of patients

“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  Systematic ayahuasca review shows changes to acute brain connectivity

“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  Study results suggest improved efficacy of DMT therapy with SSRIs 

“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.

[activecampaign form=52]

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Research

Phase 2a trial to investigate 5-MeO-DMT candidate for alcohol use disorder

Published

on

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.”

Continue Reading

Research

The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

Published

on

The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

A new study from the Hebrew University-Hadassah Medical Center has indicated that natural psilocybin extracts may demonstrate superior efficacy to synthetic psilocybin extracts.

Recent years have seen a boom in research into psilocybin for the treatment of mental health conditions such as anxiety and depression.

Many of the clinical trials investigating psilocybin use synthetic extracts rather than natural ones. This is because synthetic extracts will contain psilocybin alone, whereas natural psilocybe mushroom extracts will contain several different compounds such as psilocybin, psilocin, baeocystin and norbaeocystin.

Having multiple compounds can pose a challenge when running clinical trials as identifying which compounds are active and what their impact is becomes difficult to measure, and the concentrations of these compounds can vary depending on factors such as growth conditions and processing techniques.

This makes the standardisation of multi-compound medicines a huge challenge, as medicine consistency, reproducibility and dosing become difficult. However, these are essential factors when it comes to conducting clinical trials and receiving approval for medicines from regulators.

The Entourage Effect

In 2011 Dr Ethan Russo put forward the theory of the Entourage Effect in cannabis. 

The cannabis plant contains over 400 different cannabinoids that have so far been identified, such as THC, CBD, CBN and CBG.

Russo hypothesised that these different cannabinoid compounds work synergistically to create a therapeutic effect, as opposed to compounds such as THC or CBD working in isolation.

This hypothesis has been touched on only a few times in the scientific literature in relation to psychedelic mushrooms.

For example, in Dr Jochen Gartz’s 1989 paper ‘Biotransformation of tryptamine derivatives in mycelial cultures of Psilocybe’ which proposed a synergistic relationship between compounds in the mushrooms, and a 2015 paper by Zhuck et al, ‘Research on Acute Toxicity and the Behavioral Effects of Methanolic Extract from Psilocybin Mushrooms and Psilocin in Mice’, which observed that the effect of psychedelic mushroom extracts on mice was much stronger than pure psilocybin.

There has been very limited research on this hypothesis in mushrooms since. 

A new study: Natural may outperform synthetic

Now, a research team from Hebrew University-Hadassah Medical Center BrainLabs Center for the Psychedelic Research have compared a natural psilocybin extract to a chemically synthesised version.

Published in Molecular Psychiatry, results from the study indicate that the natural extract increased the levels of synaptic proteins associated with neuroplasticity in key brain regions, including the frontal cortex, hippocampus, amygdala, and striatum.

The ability of psilocybin to induce neuralplasticity has been indicated as one of the key features that contribute to its therapeutic effects.

The researchers suggest that these new study results indicate that nautral psilocybin extracts may offer unique therapeutic effects that may not be not achievable with synthesised, single-compound psilocybin alone. 

Metabolomic analyses also revealed that the natural extract exhibited a distinct metabolic profile associated with oxidative stress and energy production pathways.

The researchers write: “In Western medicine, there has historically been a preference for isolating active compounds rather than utilising extracts, primarily for the sake of gaining better control over dosages and anticipating known effects during treatment. The challenge with working with extracts lay in the inability, in the past, to consistently produce the exact product with a consistent compound profile. 

“Contrastingly, ancient medicinal practices, particularly those attributing therapeutic benefits to psychedelic medicine, embraced the use of extracts or entire products, such as consuming the entire mushroom. Although Western medicine has long recognised the “entourage” effect associated with whole extracts, the significance of this approach has gained recent prominence.”

However, compared to cannabis, the researchers suggest that mushroom extracts present a unique case, as they are highly influenced by their growing environment such as substrate, light exposure temperature and more.

“Despite these influences, controlled cultivation allows for the taming of mushrooms, enabling the production of a replicable extract,” the team writes.

The researchers emphasise that this research underscores the superiority of extracts with diverse compounds, and also highlights the feasibility of incorporating them into Western medicine due to the controlled nature of mushroom cultivation.

Continue Reading

Research

Ayahuasca retreats associated with increases in nature-relatedness

Published

on

Ayahuasca retreat associated with increases in nature-relatedness

A new proof-of-concept pilot study by Onaya Science found that participation in ayahuasca retreats carried out in a traditional Indigenous Amazonian context was associated with significant increases in nature-relatedness.

As highlighted by the research team, anecdotal accounts of ayahuasca experiences commonly describe strong feelings of interconnection with nature. 

“Nature relatedness” – a measure of a person’s relationship with nature – has been linked to improvements in mental and physical health. 

The authors write: “Human connection to nature is being increasingly eroded, partly through increasing urbanisation and a loss of green space, meaning increasing numbers of people are inhabiting nature-depleted environments. This is coupled with shifts in individual behavioural factors such as a greater predominance of more indoor-based sedentary lifestyles and lessened childhood play opportunities outdoors. 

See also  New report analyses amount of people drinking ayahuasca worldwide

“This can result in a diminished potential for everyday interactions with nature or an ‘extinction of experience’, and it has been suggested that this reduced capacity for nature contact and connection has detrimental implications for health, well-being, and propensity towards experiencing positive emotions.” 

The team, led by Simon Ruffell and Sam Gandy, emphasises that, while there is a range of nature-relatedness enhancing interventions such as nature immersion retreats, these may vary in their effectiveness and there is a need for reliable interventions.

Within the context of traditional Amazonian use, ayahuasca practices are deeply rooted in nature and can play a vital role in environmental decision-making. 

Ayahuasca and nature-relatedness

For the study, published in Drug Science, Policy and Law, a group of 43 participants took part in questionnaires both before and after participating in six Amazonian-led ayahuasca retreats at the Ayahuasca Foundation (AF).

The results showed that attendance at the retreats was associated with significant increases in nature-relatedness. Additionally, the team found retreat attendance was associated with improvements in depression and stress, but, not in anxiety. 

The team wrote: “Furthermore, a significant negative correlation with moderate effect size was found between changes in nature-relatedness and stress, suggesting that an increase in nature-relatedness is associated with decreased stress levels after attending Amazonian ayahuasca retreats in our sample.”

However, the team highlights that it is currently not clear whether these reported changes are due to consumption of ayahuasca, or due to the nature-based setting of the retreat. 

“Although this pilot study suggests a potential therapeutic role for Amazonian ayahuasca retreats as a multidimensional intervention, further work is required to assess the role of possible mediators underlying such shifts, while evaluating to what extent these are sustained for long term,” the team writes, suggesting that the findings demonstrate the potential of ayahuasca retreats as a multidimensional intervention that could evoke significant changes in a variety of domains.

The current study did not assess long-term nature-relatedness, however, previous research suggests psychedelic experiences may improve nature-relatedness for up to two years.

Limitations of the study are noted, such as a lack of control group, and factors that may have influenced outcomes. For example, the retreats require participants to disconnect from technology, which may have contributed to feelings of connection with nature, and the inability to carry out constituent analysis of the brew, preventing the comparison of outcomes to the levels of DMT and harmala alkaloids ingested.

Speaking to Psychedelic Health, Gandy commented: “Further research should seek to elucidate to what degree the shift in people’s connection to nature is sustained and reflected in life changes, further explore the specific factors that mediate this shift (i.e. the Amazonian rainforest retreat setting, the Indigenous shamanic context, the ‘digital detox’ or the direct pharmacodynamic effects of ayahuasca) and how it might be enhanced.

“Also, further work warranted exploring the possible additive benefits of a collective, nature-based Indigenous context vs the individualised clinical context: The potential synergistic or additive benefits of the nature-rich Amazonian rainforest retreat setting and other contextual factors such as the disconnection from technology and the nature-orientated shamanic context in influencing nature relatedness in comparison to a Western clinical context warrants further research attention.”

The team concluded: “Whilst our data suggest nature relatedness could be related to changes in mental health outcomes such as stress, our modest, uncontrolled sample does not allow for the generalisation of results. Future studies with larger samples and long-term follow up will shed more light on the initial findings presented in this pilot study.”

The team now plans to run an ‘ayahuasca-free’ retreat following the same structure as a regular ayahuasca retreat but without the ayahuasca brew to investigate the phenomenon while controlling variables.

Continue Reading

Trending