NCT04661514 is a Phase 2 clinical trial of Psilocybin in Anorexia Nervosa, sponsored by University of California, San Diego.

Who is sponsoring NCT04661514?

NCT04661514 is sponsored by University of California, San Diego.

What drugs are being tested in NCT04661514?

Interventions in NCT04661514: Psilocybin.

What condition does NCT04661514 study?

NCT04661514 studies Anorexia Nervosa.

Is NCT04661514 still recruiting?

NCT04661514 is currently completed. Last updated 25 July 2022.

Last reviewed 2022-07-25 · How we verify

NCT04661514

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

Completed Phase 2 Last updated 25 July 2022

What this trial tests

Phase 2 trial testing Psilocybin in Anorexia Nervosa in 16 participants. Completed in 10 June 2022.

Timeline

1 May 2021

Primary endpoint
10 March 2022

10 June 2022

Quick facts

Lead sponsor	University of California, San Diego
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 May 2021
Primary completion	10 March 2022
Estimated completion	10 June 2022
Sites	1 location across United States

Drugs / interventions tested

Psilocybin — full drug profile →

Conditions studied

Anorexia Nervosa — all drugs for Anorexia Nervosa →

Sponsor

University of California, San Diego

Who can join

Adults 18 to 40, any sex, with Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.

Publications & conference data

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

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
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
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
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
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
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
Ketamine as a Novel Psychopharmacotherapy for Eating Disorders: Evidence and Future Directions.
Ragnhildstveit A, Slayton M, Jackson LK, Brendle M, et al · · 2022 · cited 27× · PMID 35326338 · DOI 10.3390/brainsci12030382
Body mass index (BMI) does not predict responses to psilocybin.
Spriggs MJ, Giribaldi B, Lyons T, Rosas FE, et al · · 2023 · cited 14× · PMID 36373934 · DOI 10.1177/02698811221131994

Verify or expand the search:

Other trials of Psilocybin

Trials testing the same drug.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression · Phase 3 · not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder · Phase 1 · not yet recruiting

Other recruiting trials for Anorexia Nervosa

Currently open trials in the same condition.

NCT07169747 — Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young · Phase 2 · recruiting
NCT07237607 — Developing an Artificial Intelligence (AI) Chatbot for Adolescents and Young Adults With Eating Disorders · NA · recruiting
NCT07188155 — Adapting Exposure for Adolescent AN · NA · recruiting
NCT07143981 — The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa · recruiting
NCT07311356 — Prognosis of Early-onset Anorexia Nervosa · recruiting

Other University of California, San Diego trials

Trials by the same sponsor.

NCT07342543 — Guided Physical Activity Counseling for Hypertension in Primary Care · NA · not yet recruiting
NCT06505317 — Artificial Intelligence for Early Detection of Peripheral Artery Disease · NA · not yet recruiting
NCT07211802 — CKM For Safe Use of SGLT2i in Type 1 Diabetes · Phase 3 · not yet recruiting
NCT07524751 — Culturally Adapted Pain Management for Indigenous Peoples · NA · not yet recruiting
NCT07518784 — Accurate Point of Care Liver Disease Diagnostics (Phase 2) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04661514 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
Last refreshed: 25 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04661514.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing