Ethical and regulatory challenges for psychedelic treatments.

BACKGROUND:

Clinical trials with psychedelic substances have been conducted to find alternative treatments for mental health conditions. Clinical research has advanced under the regulation of ethical and medication authorities for clinical trials. However, psychedelic treatments present unique ethical and regulatory challenges, that must be addressed prior to approval.

METHODS:

Here, the ethical and regulatory challenges of psychedelic treatments are considered, according to the reflection of researchers involved in trials with psychedelics in Portugal, and discussions with local scientific, professional and ethical societies and authorities.

RESULTS:

Psychedelics are often administered in combination with some form of psychological support or psychotherapy, primarily for safety reasons, due to the induction of an altered state of consciousness, but also because it is thought that the psychological intervention may be critical to modulate the subjective experience associated with the drug and its clinical efficacy. Informed consent in psychological interventions, psychotherapy in particular, is an ongoing process, requiring the patient to be autonomous in decision-making throughout therapy. In psychedelic treatments, this procedure is challenged by the altered state of consciousness, the effects of which need to be fully disclosed and discussed in detail during initial informed consent procedures. Furthermore, and even in the absence of psychedelics, psychological interventions may be prone to boundary transgressions due to development of a trusting relationship. The potential for heightened suggestibility resulting from psychedelic substances may increase vulnerability to potential abuse. Information regarding this nature of the increased vulnerability of the patient must be part of enhanced informed consent procedures. In addition to optimizing consent, the right settings for psychedelic treatments must be considered as means to enhance safety for patients under altered states of mind. Finally, mental health providers will need to be given the technical and ethical tools to prepare and conduct psychological processes with patients before, during and after altered states of consciousness. Professional boards must work jointly towards professional regulation of psychedelic treatments, with development of robust risk management plans and regulation of professional credentials.

CONCLUSIONS:

Overlooking the ethical, regulatory and policy challenges anticipated for psychedelic treatments could risk halting implementation and research in the field. Development of policy and regulation for such treatments will necessarily be complex, and require joint efforts from regulatory agencies, ethical authorities, and scientific and professional societies, working together with policy makers to ensure the safety and well-being of patients.