mental-health – Psychedelic Ethics

Some notes on informed consent

I recently had cause to pen an overview of informed consent for psychedelic therapies that won’t be making its intended appearance in a journal article. Happily, I’m due to speak about informed consent at ICPR next week anyway, so this wasn’t in vain and allowed me some time to refresh my memory on the literature.

I include the text of it below, which I may cannibalise for use elsewhere (bulking out my thesis?). It’s meant as a fairly milquetoast survey of the scene, rather than an opportunity to grind any of my own axes, but as such should help orient a reader who has stumbled upon ‘psychedelicethics.com’ who is looking to learn about, well, psychedelic ethics.

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The atypical acute and long-term effects of psychedelic administration both present challenges for the practice of informed consent, which seeks to safeguard patient autonomy and support patient-defined goals for treatment. Heightened vulnerability and suggestibility during acute drug effects, as well as diminished decision-making capacity, represent risks to patient autonomy (Villiger and Trachsel, 2023); subjective effects during psychedelic experiences can include profound perceptual and cognitive changes, including alterations to sense of self and reality (Studerus et al., 2011), which as well as being hard to anticipate, can be challenging for clinicians to describe and for prospective patients to understand; while the potential for longer-term influences on metaphysical beliefs (Timmermann et al., 2021), personality (Weiss et al., 2023) and values (Kähönen, 2023) present particular challenges for deciding whether to undertake treatment.

While the signing of a consent form may be a one-off process that precedes an intervention, informed consent remains important throughout treatment. Under the acute effects of psychedelics, a patient’s decision-making capacity – itself a key requirement of informed consent – can be compromised, complicating how a clinician should respond to some patient requests, perhaps for therapeutic touch which the patient had not consented to prior to the session, or for the termination of the session itself with rescue drugs (Lee, Rosenbaum, and Buchman, 2024). Until the evidence base for outcomes relating to touch and session termination can inform best practice guidelines, scholars affirm the importance of a precautionary mindset that emphasises the need to minimise suspected risks of harm over prospects of undetermined benefits (Devenot et al., 2022a; Jacobs et al., 2024; Lee, Rosenbaum and Buchman, 2024).

Considering the unusual subjective effects and downstream side-effect profile of psychedelics, Smith and Sisti (2020) propose a consenting process which is ‘enhanced relative to that of informed consent procedures used to prescribe other psychotropics’. A third of UK nationals who would not consider a psychedelic-based treatment referenced their unwillingness to undergo a psychedelic ‘trip’ (Jacobs, 2021), suggesting that features of psychedelic treatments that are atypical in medicine are highly salient in patient decision-making processes, and must be included in any valid consenting process.

The difficulty in accurately describing the phenomenology of a psychedelic experience is well-recognised, and the often highly personal and autobiographical hallucinations that can arise cannot be predicted and explained to a prospective patient in advance. Marks et al. (2024) propose that such limitations are acknowledged with patients, while nonetheless making ‘good-faith efforts to fully inform’ them. Expanding on Smith and Sisti’s ‘enhanced consent’, many bioethicists call for the development of diverse resources to better communicate the effects of psychedelic treatment, including preliminary low doses to ‘test the waters’, access to testimony from similar users, multimedia educational materials and virtual reality to simulate some of the acute effects (Villiger and Trachsel, 2023; Jacobs et al., 2024; Marks et al., 2024; Appelbaum, 2024).

Although such efforts could improve comprehension of psychedelic treatments, some argue that the normative standards for informed consent in medicine cannot be met when treatment involves ‘transformative experiences’ (Paul, 2014), and that alternative mechanisms for safeguarding patients should be considered (Jacobs, 2023; Egerton and Capitelli-McMahon, 2023). Informed consent processes are meant to support patients in rationally deciding whether undertaking a potential treatment, with its associated risks and potential benefits, is right for them (Jacobs, 2023). But a rational choice cannot be made to undertake an experience that involves both learning something that can only be learned by having the experience, and changing in response to that experience, whether in terms of self-concept, values, or core preferences. If the subjective experience of a psychedelic treatment is inaccessible or unimaginable to me, the argument goes, or I cannot foresee who I will be or what I will care about after, my consent to treatment cannot be properly ‘informed’. Others are less concerned by this reasoning, pointing to other medical treatments that are ‘transformative’ which we accept informed consent to (Kious et al., 2024), or suggesting that a robust desire to escape the negative status quo of psychopathology can rationally ground a wish to risk a transformation (Villiger, 2024).

More pragmatically, reviews of informed consent forms for psychedelic trials have found that they may be lacking regarding highly salient features of psychedelic therapies, including the use of touch (Harrison, 2023) and the prospect of long-term changes to personality, values and worldview (Rouhe, 2022). While these features should be acknowledged during the consenting process, quite which of the many potential outcomes should be highlighted remains unclear. As for any intervention, clinicians should strive to inform without overwhelming patients (O’Neill, 2017). Detailing every possible complication, however minor and rare, could paradoxically diminish decision-making capacity by inducing patients to focus on irrelevant information or be swayed by the sheer number of negative possibilities rather than likely benefits. A particular difficulty for psychedelic practitioners arises due to the suggestibility-enhancing effects of psychedelics (Carhart-Harris et al., 2015). Devenot et al. (2022b) show that material introduced to patients in advance of drug-assisted sessions can shape acute experience and patient understanding. As such, disclosure of potential outcomes of psychedelic use, crucial to safeguard patient autonomy, may inadvertently make some outcomes more likely by contributing to patient expectations and ‘set’.

As with many dimensions of psychedelic therapies, researchers and clinicians contemplating best practice for informed consent should retain a sense of epistemic humility: in alerting prospective patients about the limitations of our current understanding of psychedelic effects, and in avoiding the premature concretization of consent practices (Appelbaum, 2024).

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Appelbaum, P. S. (2024). Informed Consent to Psychedelic Treatment—A Work in Progress. JAMA psychiatry.

Carhart-Harris, R. L., Kaelen, M., Whalley, M. G., Bolstridge, M., Feilding, A., & Nutt, D. J. (2015). LSD enhances suggestibility in healthy volunteers. Psychopharmacology, 232, 785-794.

Devenot, N., E. Tumilty, M. Buisson, S. McNamee, D. Nickles, and L. K. Ross. (2022a). A Precautionary approach to touch in psychedelic-assisted therapy. Bill of Health.

Devenot, N., Seale-Feldman, A., Smith, E., Noorani, T., Garcia-Romeu, A., & Johnson, M. W. (2022b). Psychedelic identity shift: A critical approach to set and setting. Kennedy Institute of Ethics Journal, 32(4), 359-399.

Egerton, K., & Capitelli-McMahon, H. (2023). Transformative experience and the principle of informed consent in medicine. Synthese, 202(3), 65.

Harrison, T. R. (2023). Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials. Journal of Psychedelic Studies, 7(S1), 48-60.

Jacobs, E. (2021, Jun 4.). Public attitudes to psilocybin-assisted therapy. Drug Science. https://www.drugscience.org.uk/yougov-results-is-the-uk-ready-to-reschedule-psilocybin 

Jacobs, E. (2023). Transformative experience and informed consent to psychedelic-assisted psychotherapy. Frontiers in Psychology, 14, 1108333.

Jacobs, E., Earp, B. D., Appelbaum, P. S., Bruce, L., Cassidy, K., Celidwen, Y., … & Yaden, D. B. (2024). The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement. The American Journal of Bioethics, 1-7.

Kähönen, J. (2023). Psychedelic unselfing: self-transcendence and change of values in psychedelic experiences. Frontiers in Psychology, 14, 1104627.

Kious, B. M., Peterson, A., & McGuire, A. L. (2024). Are Psychedelic Experiences Transformative? Can We Consent to Them?. Perspectives in Biology and Medicine, 67(1), 143-154.

Lee, A., Rosenbaum, D., & Buchman, D. Z. (2024). Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations. The Canadian Journal of Psychiatry, 07067437231225937.

Marks, M., Brendel, R. W., Shachar, C., & Cohen, I. G. (2024). Essentials of Informed Consent to Psychedelic Medicine. JAMA psychiatry.

O’Neill, O. (2017). Some limits of informed consent. In The Elderly (pp. 103-106). Routledge.

Paul, L. A. (2014). Transformative experience. OUP Oxford.

Rouhe, J. (2022). How informed is the informed consent in clinical trials with psychedelics? A review of the state of patient autonomy in therapeutic studies with psychedelic drugs. [Master’s thesis, University of Eastern Finland]

Smith, W. R., & Sisti, D. (2021). Ethics and ego dissolution: the case of psilocybin. Journal of medical ethics, 47(12), 807-814.

Studerus, E., Kometer, M., Hasler, F., & Vollenweider, F. X. (2011). Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies. Journal of psychopharmacology, 25(11), 1434-1452.

Timmermann, C., Kettner, H., Letheby, C., Roseman, L., Rosas, F. E., & Carhart-Harris, R. L. (2021). Psychedelics alter metaphysical beliefs. Scientific reports, 11(1), 22166.

Villiger, D. (2024). Giving Consent to the Ineffable. Neuroethics, 17(1), 1-16.

Villiger, D., & Trachsel, M. (2023). With great power comes great vulnerability: an ethical analysis of psychedelics’ therapeutic mechanisms proposed by the REBUS hypothesis. Journal of Medical Ethics, 49(12), 826-832.

Weiss, B., Sleep, C. E., Beller, N. M., Erritzoe, D., & Campbell, W. K. (2023). Perceptions of psychedelic personality change, determinants of use, setting and drug moderation: Toward a holistic model. Journal of Psychedelic Studies, 7(3), 200-226.

Psychedelic Alpha – Annotated Research Bibliography of 2023

In support of Psychedelic Alpha’s Annotated Research Bibliography of 2023, I was asked to write a brief comment on a few of the papers from last year that I thought were particularly deserving of attention. I’d highly encourage that you click through on the link above to take in the combined recommendations of a thirty-odd cohort of researchers, though I include below my three contributions.

British cultural norms towards modesty were this time beaten out by a junior researcher’s need to self-publicise, so I wrote about my own co-authored paper on Post-Trial Access and Care (full version available here), as well as a couple of articles on the question of personal psychedelic experience for psychedelic therapists, and on the leveraging of psychoanalytic frameworks for better understanding the journey of clinical trial participants treated for treatment-resistant depression.

For each paper, there is much more that could be said than the ~700 word limit allowed. So maybe these hot takes will see fuller accounts in the future.

Emmerich, N., & Humphries, B. (2023). Is the Requirement for First-Person Experience of Psychedelic Drugs a Justified Component of a Psychedelic Therapist’s Training? Cambridge Quarterly of Healthcare Ethics, 1–10. Advance online publication. https://doi.org/10.1017/S0963180123000099

With psilocybin entering the last stages of safety and efficacy testing that will lead to its licensing, attention is now turning to the nuts and bolts of how psychedelic therapies will be rolled out at a large scale. In that context, this paper asks an important and timely question about how tomorrow’s psychedelic therapists will be best prepared for delivering a new modality of treatment.

Emmerich and Humphries’ answer to the question they pose is ‘no’, arguing that whatever epistemic benefits a therapist may derive from their own psychedelic experience (i) might otherwise be garnered to a sufficient degree by other means holotropic breathwork or ‘the Dreamachine’, and, besides, (ii) there is as yet no strong evidence that personal psychedelic experience would improve their competence as a psychedelic therapist. Against this background, the authors suggest that the principle of autonomy – the trainee therapist’s autonomy – should win out, and that personal psychedelic experience should be optional.

Like many aspects of clinical practice in psychedelic therapies, the norm of personal experience for therapists is an inheritance of the first wave of research in the ‘50s and ‘60s. In the absence of RCTs to determine the impact of therapists’ psychedelic experience on patient outcomes (two attempts last century were unfortunately thwarted before analysis could be completed), it is hard to determine which measures are historically contingent traditions, and which are borne of accumulated, if non-systematic, clinical judgement. Perhaps I am overly risk-averse, but in retrofitting psychedelic therapy for a modern, mass roll-out, there is a real threat that we go about ripping up Chesterton’s fence in the absence of the right kind of evidence that speaks to whether it should stay or go.

The authors note (and seem to endorse) the requirement that, outside psychedelic contexts, therapists must undergo their own therapy. But there’s more to be said here: it is not all modalities that require personal experience of therapists. A significant range of three-letter, behavioural therapies (CBT, CFT, SFT, DBT, etc) do not require personal experience; whereas all psychodynamic and psychoanalytic practices do. In those domains, personal experience of therapy is needed to internalise the theoretical framework of the practice, understand what it feels like to be in the patient’s position, and to better understand the subtle and complex features of the psyche, including the manifestations of transference and countertransference in the therapy room. Indeed, the more personal psychotherapy a practitioner has had, the better able they are to identify potential countertransference issues. In sum, there is lots of psychic terrain you must learn to navigate to practise such a modality, and personal experience of therapy is the only way to map it.

As such, the question of whether psychedelic therapists must have their own psychedelic experience, might really be a question of whether psychedelic therapy is more akin to CBT or psychodynamic therapy in this regard. My own sense is that navigating the subtle and complex terrain of the psychedelic experience towards healing will be best done by those who have done more than read the travel blogs or travelled to broadly similar climes, but I fear these questions may be swept away by the larger battle set up by the year’s most controversial paper, “Must psilocybin always assist psychotherapy?” One answer to that question minimises the importance of practitioners’ personal experience.

Of Emmerich and Humphries’ arguments against demanding personal experience for practitioners, I find most compelling the example of otherwise competent therapists who, due to some contraindication or another, cannot undertake a psychedelic experience themselves, and I struggle to find an answer that I am satisfied with. I think that, until better evidence comes in, psychedelic therapists should have their own experience, and that demand must fall on those who cannot have a psychedelic experience as those who will not. Nonetheless, the progress of psychedelic science and practice needs psychedelic naive people: psychedelic experiences can be, as we know, one of the most meaningful experiences in many people’s lives. And I can’t help but think that a group of people – even scientists – who all share a high-saliency, positive attitude for some experience, are not going to come to the most accurate conclusions about it, in the absence of others to serve as a reality check.

Maggio, C., Fischer, F.M., Modlin, N.L., Rucker, J. (2023). Psychoanalytic Formulations in Psychedelic Assisted Psychotherapy for Treatment Resistant Depression (TRD). Journal of Psychology & Psychotherapy, 13:451. DOI: 35248/2161-0487.23.13.456

In explaining the state of knowledge in psychedelic-assisted therapies to people I often invoke the image of a console with dozens and dozens of switches and dials, the setting of each of which might have some impact on the acute and downstream effects of the treatments. The cumulative research of the mid-20th Century and the last two decades has managed to nail down, with some confidence, the role of a good number of these settings. There remain many more dials that we don’t yet know the best settings for – a natural situation for any nascent field, not least one that revolves around a controlled, as-yet-unlicensed, drug. We will get to adjusting some of the bigger, shinier dials once psychedelics are more widely available clinically: how many drug sessions is best, and at what interval? How much integration is needed, and what level of clinical training should be required for those supporting this process?

Among those big questions that we’re still not sure about – which therapeutic modalities should contain and support clinical psychedelic administration? – is to me one of the most salient. With some researchers last year already proposing that we should consider third-wave behavioural therapies as default, this paper is important for reopening space for the inclusion of psychoanalytic frameworks for understanding psychedelic therapies. The authors point out that at least some of these frameworks, which prioritise the workings of the unconscious, receive a ‘silent agreement’ in much psychedelic therapy anyway, given that the drugs are widely conceived as ‘mind-manifesting,’ tending to make visible otherwise unconscious material.

Explaining how the treatment of two individuals in a trial of psilocybin for treatment-resistant depression can be understood in psychoanalytic terms, the authors seek to ‘[challenge] a paradigm that may compartmentalise patients’ experience by breaking it down into its component parts to fit a familiar and finite scientific model’. When psychedelic treatments are licensed, it may be that insurers will only pay for interventions involving the so-called ‘evidence-based’ models of therapy. Even so, the article demonstrates how psychoanalytic thinking can still be valuably deployed to better manage intake, preparation, and patient care during psychedelic treatments.

Firm sceptics of psychoanalytic approaches are not going to be converted by this article, but I nonetheless recommend its addition to your ‘to-read’ list. More than any other paper this year, this article clearly communicates a curiosity and human respect for the profundity of the psychedelic experience, both of which can regrettably come out in the wash when preparing a scientific article according to contemporary publishing norms.

Jacobs, E., Murphy-Beiner, A., Rouiller, I., Nutt, D., & Spriggs, M. J. (2023). When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research. Neuroethics, 17(1), 3. https://doi.org/10.1007/s12152-023-09536-z

This paper, which I co-authored with a group of researchers from Imperial’s Centre for Psychedelic Research and a former participant in one of their trials, was borne out of findings that have repeatedly been mentioned in passing in the literature, but not paid any sustained attention. A number of participants, following a psychedelic trial, will either seek out further psychedelic experiences, or begin further psychotherapy as individuals.

These choices are worth taking seriously: in many cases they reflect otherwise treatment-resistant patients “desperately grasping to retain the benefits from psychedelic therapy,” as our patient co-author put it, or participants finding that the trial initiated, but did not complete, a process of psychological work that they could not opt out of, but had to find external help in concluding. In my own research interviews with former trial participants, one described her experience as being “ripped open, left with all the mess and having to deal with it on my own.” Cases of both kinds indicate an unmet need that has been awoken by the trial: a need that should, we argue, be fulfilled by those responsible for running trials.

In making this argument, we effectively question whether the traditional norms of clinical research ethics are appropriate for psychedelic trials. Several features of psychedelic treatments – including the illicit availability of the experimental drugs, the risk of trial endpoints coming too soon to end therapy safely, and the lack of psychedelic integration expertise in the mainstream healthcare system – suggest that simply referring trial participants back to existing support is not sufficient.

Our recommendations are, we acknowledge, expensive ones, especially in the context of already resource-intensive trials. But a participant’s journey doesn’t end with the conclusion of the trial, and our responsibility to them extends beyond it. By providing post-trial access and care where clinically indicated, we could also gain valuable insights about long-term support that will help build the well-functioning psychedelic ecosystem of tomorrow. Research trial norms can take time to change, but we hope this paper invites reflection on how the practice of future clinical trials might improve participant experiences. They are, after all, the very people who make progress in psychedelic science possible.