Toward enhanced consent for psychedelic psychiatry

By William R Smith. and Dominic Sisti.

Imagine living with treatment-resistant depression. You’ve already tried several lines of medication, electroconvulsive therapy, and psychotherapy to no avail. You might have even have used augmentation strategies such as transcranial magnetic stimulation. Maybe you have spent years of your life struggling with this disease despite these attempts; maybe you do not even remember what it feels like to not be depressed.

Now imagine an experimental treatment that appears to offer benefit to 45% of patients like you and, in 25% of patients, full remission of depression.

That treatment is psilocybin, the active ingredient in “magic mushrooms.” It, and several of its psychedelic relatives, are showing promising results in treating a wide variety of conditions. But these results are in early trials, and phase 3 trials are largely just beginning. (The trial with the promise of benefit to people like you was an open-label trial of 20 patients).

Would you want to try psilocybin? What would you want to know before doing so? What should researchers be disclosing to you during the informed consent process if you join a phase 3 trial? What should clinicians be disclosing to you if psychedelic treatment moves to from the bench to the bedside (as appears quite likely) and you are one of their patients considering psychedelic therapy?

In determining whether to try psilocybin, you might want to read the growing accounts of results in the popular press. But you might also want to know what’s different about this treatment from more conventional therapies, such as selective serotonin reuptake inhibitors. In particular, because benefits of the treatment correlate with characteristic psychedelic phenomenology during the treatment and that tends to also create significant changes in personality and values, you may want to think about what this might mean for you. You might also want to know about potential mental health risks, and whether and how therapists might use therapeutic touch if you encounter significant anxiety that is characteristic of the experience.

Little attention has been paid to this issue, and our new paper in the Journal of Medical Ethics aims to address this gap by looking specifically at the case of research and clinical use of psilocybin-assisted psychotherapy. We attempt to address these issues and show that they are particularly important to consent to psychedelic psychotherapy in marked contrast to other conventional psychopharmacology and psychotherapy.

Thus, we propose that the consent process to psilocybin should be one of, what we call, “enhanced consent”—one that is enhanced relative to that of informed consent procedures used to prescribe other psychotropics in requiring greater attention to the topics above. These issues are characteristic of psychedelic treatment, but also relatively distinctive of it in that other medical and psychiatric interventions are less likely to raise this set of concerns. Nevertheless, our account of enhanced consent to psychedelic psychotherapy is based on and consistent with established principles of informed consent. Our paper aims to show how those principles require enhanced consent.

Finally, as readers of the Journal of Medical Ethics, you might also wonder whether other ethical issues might arise as psychedelic agents move from the realm of contraband to that of accepted medication. Is all this talk of personality and value change simply another case ethics worries that has proven unfounded in other cases such as solid organ transplant, deep brain stimulation, and face transplant? What policy safeguards are necessary to maintain high quality work with low risk as we move from tightly-controlled research environments to clinical practice? Is psychotherapy, which can prove quite expensive overtime, needed or is the medication itself the therapy as many believe the medications for substance treatment have proven to be?

We aim to broach some of these critical questions. Though our answers are merely preliminary in these cases, we hope they open the discussion. Yet, throughout the history of psychiatry, repeated therapies have been championed, and yet many of them recurrently fail with most of our best treatments being more than 40 years old. Hence, we must ensure that research persists and care is given in the setting of such great enthusiasm about psychedelic agents. Nevertheless, we are eager about the potential success of psychedelic psychotherapy and hope that our discussion of these ethical issues will help ensure that its use is just as ethical as potentially beneficial.


Paper title: Ethics and ego dissolution: the case of psilocybin

Author(s): William R Smith1 and Dominic Sisti2


1 Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA 2 Department of Medical Ethics and Health Policy, Philadelphia, Pennsylvania, USA

Competing interests: None.

Social media accounts of post author(s): @domsisti

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