Psychedelics as Medicine: Expert Interview with Dr. Henrik Jungaberle in “Psych Report 2021”
Since the turn of the century, there has been a resurgence of research into psychedelics as medicines. In 2021, MAPS published the first results from its phase IIIa clinical trial to treat PTSD with MDMA-assisted psychotherapy, and COMPASS Pathways completed its phase IIb study into psilocybin’s efficacy against treatment-resistant depression. As companies position themselves to treat patients with psychedelic-assisted psychotherapy, what do you see are the biggest roadblocks to the widespread accessibility of psychedelics?
I think that the last part of the journey can be the hardest. From phase II to phase III and everything that happens after phase III, when companies are negotiating with regulators. That is when the authorities will talk about risk mitigation strategies, setting up the criteria on how the medicines will be applied. This is the challenge that will soon be faced by MAPS, COMPASS Pathways and all those that try to gain approval for psychedelics as medicines.
The second bottleneck or challenge that I see is the training of psychedelic therapists. Rick Doblin of MAPS recently said that he wants to train 24.000 therapists. I think the strategy or the goal to train a lot of therapists in a very short timeframe could be very challenging to not only MAPS but the whole field. I hope that we will be able to keep the quality of training high because there could be a real big backlash when we finally get to real life implementation and phase IV studies, which serve the purpose of further risk-benefit assessment in larger patient collectives and/or special patient groups to determine the therapeutic significance with more practical relevance in “naturalistic environments”. This is to identify if a drug really holds the promise in the field that it was approved for.
If we train a lot of unreliable therapists who misleadingly think psychedelic therapy consists of giving a drug to a person or “tripping” it could derail the whole process. To avoid this, we need to ensure that training is done at high quality and that we assess therapist’s capabilities properly before they enter the trainings, especially before they embark on short online training programmes. I am personally sceptical that these courses will provide the skills people need in the first generation of modern psychedelic therapists.
To bring psychedelics to market, therapists will need to be trained to offer new forms of therapy. How do you think we can train these therapists, and what kind of training do they need? The MIND Foundation is training therapists through its Augmented Psychotherapy Training (APT). Can you elaborate on this two-year programme and what skills therapists will obtain?
The MIND Foundation has worked hard in the last few months to build a curriculum that is different from what we currently see in the field. The APT curriculum is a two-year 400-hour training in-depth programme. Our concept was to build the long version of the curriculum first and then develop medium and five-day intensive versions of the training.
We consider psychedelic-assisted therapy to be psychotherapy – not an exceptional and mysterious thing. The embedding into the mental health care context, the screening and treatment planning, the preparation sessions, the dosing session, the after care/integration and follow-up activities. All of the therapy sessions are important, it is not some kind of magic pill therapy or psychedelic pharmacotherapy with a little bit of preparation and integration.
Instead, the APT training is looking at how the psychotherapy process is intensified, expanded or sometimes accelerated. We are training people either to become certified psychedelic therapists or co-therapists that can work alongside other therapists in a coherent team. These therapists could come from a broad spectrum of alternatively trained disciplines, too.
Other things stand out in our training program. The first is that we believe in training therapists to become group players – with medical doctors and psychotherapists working closely together. The second is that we are also training people in non-pharmacological methods and for atypical psychedelics like ketamine – as well as for serotonergic psychedelics like psilocybin. We want therapists to be familiar with a broad pharmacopoeia and a diversified toolset to alter consciousness. Then, in the outcome-based training (OBE) that we created we involve techniques like patient actors, mentoring and mindfulness meditation.
The last characteristic of APT is its deep focus on integration. We are basing the curriculum, and the whole therapeutic process, not only on the latest therapy models such as Acceptance and Commitment Therapy (ACT). We are applying an integrative psychotherapy theory and teach the so-called general change mechanisms, as they have been shown to be effective by psychotherapy research in the last 50 years. This is the work of Jerome Frank in the US, but much more the work of the groups around Klaus Grawe, a German-Swiss psychotherapy researcher who worked at the University of Basel. They have shown that independent of certain schools of therapy, there are five common underlying factors present in effective psychotherapies, and this is the theoretical basis that we are building the APT training upon.
In your latest research article, co-authored with Prof. Dr med. Gerhard Gründer, titled ‘The Potential Role of Psychedelic Drugs in Mental Health Care of the Future’ you recognise the different aspects needed to integrate psychedelics in mental healthcare. Can you elaborate on the role of screening in this process? Will psychedelics be available to most patients or only a small group?
In our paper, we describe a six-step model (see above), not only the three most known – preparation, dosing and integration. When you look at how things are already done in real-life therapy within an existing mental health system it gets a little bit more complex. For example, before a patient arrives at our OVID Clinic in Berlin, the first two steps have already taken place as a lot of our patients are referred by other doctors, psychotherapists, or even other patients.
Future psychiatric therapists will have to build referral systems and train non-psychedelic therapists so that they know who to send and who not to send. And following the end of psychedelic therapy, some patients will still be vulnerable and some will have setbacks, so a non-psychedelic psychotherapist will have to continue with the therapy or provide a stabilising role because it is simply not the reality that people all get magically better forever.
Keeping that in mind, we do want to reach a large group of patients. But reaching a large
group without the correct approach could have dire repercussions and nobody wants that. Having qualitative screening procedures in place will ensure that we reach a large group, but also that treatments are successful.
Our experience at OVID, MIND Foundation’s clinical sister organisation that today is providing ketamine- and breathwork-assisted psychotherapy, is that turning down unsuitable patients builds trust within our referral system. By having a good screening procedure, referring doctors know that we are not here just to “drop acid” into somebody’s organism and hope that it magically works. It does help, but you really have to build the context and care for the long-term perspective of the patients.
We do not know yet if psychedelic therapies make healing processes faster though. This is not what the studies show yet and will be the terrain of comparative and phase IV studies. Current studies show that for a large proportion of study participants, psilocybin has been very effective and that the effects endure for some months, but not for all patients. Building on our psychiatric and psychotherapeutic experience, we believe that psychedelic therapists and psychotherapists largely play the same role in the treatment. Outside of the therapists’ office, both connect the patients to a social ecosystem that helps them to get better.
Psychedelic-assisted therapy (PAT) has shown some incredible results in clinical studies. Some follow-up studies have found lasting positive effects up to five years later. At the same time, other studies, mainly with ketamine, find acute positive effects which seem to dissipate within the first month. Do you think that psychedelics will be something a person with a mental health disorder should go back to periodically, or is it a one-treatment and done deal?
This is one of the extremely thrilling components of PAT that need to be worked out much more. It is very likely that a number of patients will have to return to psychedelic therapy from time to time. The phase IV studies will show who will have to come back and at what intervals. People will also come for different reasons, with psychopathology and self-development being disparate scenarios.
A patient who has struggled with depression for 30 years may find great relief after one or two psychedelic sessions like our colleagues are already beginning to see in the German EPIsoDE study (Efficacy and Safety of Psilocybin in Treatment-Resistant Depression in Mannheim and Berlin with 144 patients). But the psychosocial system around them that stabilises their pathologies will not just go away for everybody. For many patients, we may need another session, two or more each year.
For self-development, we are at an even earlier stage. The MIND Foundation is beginning to have conversations with legal authorities and politicians. Which systems of law, legal regulation or architecture need to be created around psychedelic use for healthy people? In medicine, we have the term ‘prophylaxis’, meaning treatment given or action taken to prevent disease. Part of these processes could be seen as prophylaxis, with psychedelic therapy for personal growth preventing the deterioration of mental health. The study of psychedelic use for personal growth and insights should also become part of the fields in the years to come.
OVID, MIND’s sister organisation, is offering augmented psychotherapy, meaning you augment psychotherapy either with non-pharmaceutical methods or with ketamine, and in the future with other psychedelics. Is this treatment currently supported by insurance? From your perspective, what evidence is needed for insurance to pay for these treatments?
Public health insurance companies do not pay for PAT in Germany at the moment, but we have some private health insurance companies that have begun to pay for it, which is great progress already. The effectiveness of PAT has never been demonstrated in Germany, nor in many other countries, so we do need to generate this data for insurers to justify paying for PAT. That way the treatments become available to more than only those who can afford to pay for it themselves or can be enrolled in our diversity programmes.
We do not only have to show that PAT has a slight advantage compared to talk therapy, but also that it is better than electroconvulsive therapy (ECT) for example – as that is what it is being compared to. This is the reality of the medical system and we need to do head-to-head comparison studies with the current gold standards, such as ECT, behavioural therapy and antidepressants.
In the long-term though, in order for people to have access to these therapies, we need to bring them into public health care systems. This is different in the EU from the United States. Here in Germany, the Netherlands, Switzerland, and the Mediterranean countries, we need to get it covered by public health care systems. We need to talk to insurers, public health officials, and learn from other experts to set up these studies so they are done well.
Your colleague Prof. Dr med. Gerhard Gründer is leading the phase IIb Efficacy and Safety of Psilocybin in Treatment-Resistant Depression (EPIsoDE) study, which has received more than €2 million from the German government. Why is it necessary to undertake this study as others such as COMPASS Pathways and the Usona Institute are doing similar studies?
The EPIsoDE study serves several societal and scientific goals. Our study is unique in that it provides two 25 mg doses of psilocybin and it is being tested against two different placebos. This will give us much more information about which placebo we can best use going forward in future studies.
We will also train our MIND and OVID staff with this study, prepare them to work on studies with other psychedelics or mental health disorders and involve them in the APT training for future psychedelic therapists. We have not talked about it publicly yet, but we are currently negotiating cooperation between OVID and public universities to conduct future studies together.
We also want to make the German medical and psychotherapy system aware that this kind of therapy can be performed safely within the system. There is a lot of resistance and if you want to overcome resistance, you have to do it on a country by country level in the EU. We are aware of the impressive results from US-American and multi-national studies, but their outcomes are largely confined to the psychedelic bubble still, and is not knowledge shared by mainstream psychiatrists and psychotherapists. They either do not know about it or they are not taking it seriously. If you want to get novel treatments to patients, you have to convince those who work in the traditional system.
This takes us back to the six-step process around psychedelic therapies that we talked about earlier. The referral system needs to be informed. At OVID, we have monthly referral system meetings, online and onsite, for colleagues from Berlin and globally. Colleagues in the US and Canada, where ketamine clinics are already more prolific, still seem to face a lot of resistance and medical professionals are not referring patients for these types of therapies at a large scale yet.
In Blossom’s survey, featured earlier on in the report, 65% of participants were aware of the use of psychedelics for the treatment of mental health conditions. This is already an amazing number, at the same time much more education is needed. Can you highlight how the MIND Foundation and OVID are filling this role?
We are currently in the fifth year of the MIND Foundation’s existence and year two of OVID. In these first five years, MIND has focussed a lot on the academic system. Now, we have ten programmes in place that help educate and connect everyone, from established researchers to therapists, students and junior academics. The emphasis for the next five years will be translating academic knowledge into public awareness, so people have the information to build a critical assessment of the results that psychedelic treatments can produce.
Our educational programmes, such as Footsteps and BEYOND EXPERIENCE help a wider audience gain an understanding of altered states of consciousness, and how they can use these altered states of consciousness to create a better life. We want to expand that these programmes for everyone by training more facilitators so that switching in and out of altered states of consciousness is normalised and integrated into a framework of integration.
Additionally, this year we will hand out several awards at the INSIGHT conference, our bi-yearly psychedelic research conference and on November 26th, the fifth anniversary of MIND. The goal is to raise awareness and create recognition for the junior and senior pioneers in the field. And to help them be taken seriously in the wider scientific community. This is also why we are providing endowed awards. The MIND Foundation Award will come with a €4.000 grant, and the Willy Schweitzer Young Researchers Award comes with € 1.000 due to generous donors.
Finally, our aim is to change the perspective from a drug-centred model, which is also very present in the psychedelic field, and includes the magic pill narrative, to an integration-centred model. Integration is about transforming experience into health and happiness related behaviours. Integration is all about creating a better life beyond altered states of consciousness. We are not there yet as a field, but putting a little bit more focus on integration in the next ten years will serve everyone well – those looking for healing and those looking for growth.
We cannot do it alone; a lot of organisations will need to work together and steer the field into the next generation. Not only by replicating scientific results but also by translating science into real-life practices and using all our creativity to build up-to-date, secular spiritualities that invite people to steer out of esoteric self-referral. Thereby, we have a chance to build a place for psychedelics in modern societies.
October 17th, 2021
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The Psychedelics as Medicine Report: Third Edition is an industry report outlet. It describes itself as “a premium business-to-business media and content platform for the psychedelic science and healthcare industry. Part of Psych Capital Plc.”. As such it tries to collect “consumer insights and market intelligence from experts and industry leaders, helping investors cut through the noise and identify real opportunities.”
Dr. Henrik Jungaberle has been interviewed for the report by Floris Wolswijk. Henrik is not involved with and has not been paid for the interview by either of the parties who produced or sponsored the report. His views are his own.