Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study"

Meg J Spriggs, Hannah M Douglass, Rebecca J Park, Tim Read, Jennifer L Danby, Frederico J C de Magalhães, Kirsty L Alderton, Tim M Williams, Allan Blemings, Adele Lafrance, Dasha E Nicholls, David Erritzoe, David J Nutt, Robin L Carhart-Harris, Meg J Spriggs, Hannah M Douglass, Rebecca J Park, Tim Read, Jennifer L Danby, Frederico J C de Magalhães, Kirsty L Alderton, Tim M Williams, Allan Blemings, Adele Lafrance, Dasha E Nicholls, David Erritzoe, David J Nutt, Robin L Carhart-Harris

Abstract

Background: Anorexia nervosa (AN) is a serious and life-threatening psychiatric condition. With a paucity of approved treatments, there is a desperate need for novel treatment avenues to be explored. Here, we present (1) an overview of the ways through which Public Patient Involvement (PPI) has informed a trial of psilocybin-assisted therapy for AN and (2) a protocol for a pilot study of psilocybin-assisted therapy in AN currently underway at Imperial College London. The study aims to assess the feasibility, brain mechanisms and preliminary outcomes of treating anorexia nervosa with psilocybin. Methods: (1) PPI: Across two online focus groups, eleven individuals with lived experience of AN were presented with an overview of the protocol. Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of "recovery" from the perspective of those with lived experience. (2) Protocol: Twenty female participants [21-65 years old, body mass index (BMI) 15 kg/m2 or above] will receive three oral doses of psilocybin (up to 25 mg) over a 6-week period delivered in a therapeutic environment and enveloped by psychological preparation and integration. We will work with participant support networks (care teams and an identified support person) throughout and there will be an extended remote follow-up period of 12 months. Our two-fold primary outcomes are (1) psychopathology (Eating Disorder Examination) across the 6-month follow-up and (2) readiness and motivation to engage in recovery (Readiness and Motivation Questionnaire) across the 6-week trial period. Neurophysiological outcome measures will be: (1) functional magnetic resonance imaging (fMRI) brain changes from baseline to 6-week endpoint and (2) post-acute changes in electroencephalography (EEG) activity, including an electrophysiological marker of neuronal plasticity. Discussion: The results of this pilot study will not only shed light on the acceptability, brain mechanisms, and impression of the potential efficacy of psilocybin as an adjunct treatment for AN but will be essential in shaping a subsequent Randomised Control Trial (RCT) that would test this treatment against a suitable control condition. Clinical Trial Registration: identifier: NCT04505189.

Keywords: anorexia nervosa; clinical trial; eating disorder; electroencephalograph (EEG); magnetic resonance imaging (MRI); psilocybin; psychedelic-assisted therapy; public patient involvement (PPI).

Conflict of interest statement

RC-H reports receiving consulting fees from COMPASS Pathways, Entheon Biomedical, Mydecine, Synthesis Institute, Tryp Therapeutics, and Usona Institute; DE receiving consulting fees from Field Trip and Mydecine and Entheon Biomedical; and DJN receiving consulting fees from Awakn, H. Lundbeck, and Psyched Wellness, advisory board fees from COMPASS Pathways, and lecture fees from Takeda Medical Research Foundation and owning stock in Alcarelle. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Spriggs, Douglass, Park, Read, Danby, de Magalhães, Alderton, Williams, Blemings, Lafrance, Nicholls, Erritzoe, Nutt and Carhart-Harris.

Figures

Figure 1
Figure 1
Study timeline. Grey background represents the active trial period. Blue represents pre- and post-trial periods. Yellow, green and orange represent preparation, dosing and integration respectively. Time intervals between each study day (remote or visit) for the active period are included on the left of the figure.

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