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RecruitingPhase 2

Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa

NCT07169747 · psiAN · Region Skane

Recruiting
Status
Accepting participants
Phase 2
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • To assess the safety and tolerability of psilocybin 25 mg in young adults with anorexia nervosa, as measured by incidence of adverse events (AEs) and serious adverse events (SAEs).

    Measured over From first dosing to the end of trial 12 month post-baseline.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

16 Years to 35 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission. * Have experienced at least one period of weight restoration to a minimum BMI of 17 followed by subsequent weight loss. * Age 16-35 * BMI \>16 * Stable contact with a psychiatric unit * Ability to provide informed consent Exclusion Criteria: * Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use. * Cardiovascular conditions * Resting systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg at screening or baseline * Clinically significant arrhythmias, tachycardia and QT prolongation * History of stroke, myocardial infarction, or other significant cardiovascular events * Seizure disorders or history of epilepsy * Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia * Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion * Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results * Care under the Swedish Compulsory Psychiatric Care Act (LPT) * Ongoing treatment with medications that have clinically relevant 5-HT2A-receptor antagonistic properties and are therefore expected to directly block or substantially interfere with the pharmacodynamic effects of psilocybin. Such medications require an appropriate washout period prior to psilocybin administration, based on pharmacokinetic properties and clinical judgement. Medications without direct 5-HT2A-antagonistic effects are not excluded on this basis. * BMI \> 21.0 for ≥ 6 consecutive months within the 12 months prior to screening, as documented in medical records.

Where

1 study site

FacilityCityRegionCountry
Psykiatrikliniken, Baravägen 1LundSweden

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07169747 on ClinicalTrials.gov →

Last updated in the registry 2026-08-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance