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 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.

“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.

“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.

“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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