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

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.

SUBMITTER: Spriggs M

PROVIDER: S-EPMC8563607 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Anorexia nervosa is a serious disorder, which often takes a chronic course. Early treatment leads to a significantly better prognosis and prevents chronicity. However, existing evidence on facilitators and barriers in anorexia nervosa treatment initiation is scarce. AIMS:Against this background, the FABIANA study (ClinicalTrials.gov Identifier: NCT03713541) aims to (a) identify potentially modifiable facilitators and barriers from the perspectives of adolescent and adult patients with anorexia nervosa, carers and physicians, (b) develop and test an instrument for the combined assessment of multiple key facilitators and barriers, and (c) quantify the effect of potentially modifiable versus non-modifiable key facilitators and barriers on the duration of untreated illness (DUI) in patients with anorexia nervosa. METHOD:FABIANA is an observational, mixed-method-study divided into three consecutive substudies each corresponding to one of the study aims. All three substudies will include female patients with anorexia nervosa aged 14 years and older at the beginning of their first psychotherapeutic anorexia nervosa treatment. The qualitative substudy I and the quantitative substudy III will additionally include carers and involved physicians. The recruitment will take place at 20 cooperating study centres throughout Germany, which provide in-patient or out-patient anorexia nervosa specialist care. The DUI will be calculated based on the month of illness onset as determined in validated interviews on lifetime anorexia nervosa symptoms and the therapist-reported date of treatment initiation. CONCLUSIONS:Strengths and limitations of the retrospective assessment of the DUI will be discussed. The findings of the FABIANA study will contribute to the development of evidence-based early-intervention approaches and the prevention of a chronic course of illness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03713541. DECLARATION OF INTEREST:None.

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

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