NCT04052568

Effects of Psilocybin in Anorexia Nervosa

Completed Phase 1 Last updated 6 May 2023

What this trial tests

Phase 1 trial testing Psilocybin in Anorexia Nervosa in 22 participants. Completed in 20 April 2023.

Timeline

26 August 2019

Primary endpoint
5 January 2022

20 April 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	26 August 2019
Primary completion	5 January 2022
Estimated completion	20 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Psilocybin — full drug profile →

Conditions studied

• Anorexia Nervosa — all drugs for Anorexia Nervosa →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 65, any sex, with Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive Interpersonal Model for Anorexia Nervosa Revisited: The Perpetuating Factors that Contribute to the Development of the Severe and Enduring Illness.
   Treasure J, Willmott D, Ambwani S, Cardi V, et al · · 2020 · cited 134× · PMID 32120847 · DOI 10.3390/jcm9030630
2. Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study.
   Peck SK, Shao S, Gruen T, Yang K, et al · · 2023 · cited 80× · PMID 37488291 · DOI 10.1038/s41591-023-02455-9
3. Study Protocol for "Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study".
   Spriggs MJ, Douglass HM, Park RJ, Read T, et al · · 2021 · cited 47× · PMID 34744825 · DOI 10.3389/fpsyt.2021.735523
4. Acute and long-term effects of psilocybin on energy balance and feeding behavior in mice.
   Fadahunsi N, Lund J, Breum AW, Mathiesen CV, et al · · 2022 · cited 41× · PMID 35953488 · DOI 10.1038/s41398-022-02103-9
5. Psychedelic Therapy's Transdiagnostic Effects: A Research Domain Criteria (RDoC) Perspective.
   Kelly JR, Gillan CM, Prenderville J, Kelly C, et al · · 2021 · cited 36× · PMID 34975593 · DOI 10.3389/fpsyt.2021.800072
6. Rethinking Therapeutic Strategies for Anorexia Nervosa: Insights From Psychedelic Medicine and Animal Models.
   Foldi CJ, Liknaitzky P, Williams M, Oldfield BJ. · · 2020 · cited 33× · PMID 32116500 · DOI 10.3389/fnins.2020.00043
7. Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
   Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
8. Psilocybin restrains activity-based anorexia in female rats by enhancing cognitive flexibility: contributions from 5-HT1A and 5-HT2A receptor mechanisms.
   Conn K, Milton LK, Huang K, Munguba H, et al · · 2024 · cited 27× · PMID 38678087 · DOI 10.1038/s41380-024-02575-9