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

Sponsor
Region Skane
Study ID
NCT07169747
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
16 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    The intervention consists of two oral doses of 25 mg synthetic psilocybin administered in a controlled clinical setting, combined with psychological support. The psychological support includes preparatory sessions prior to psilocybin administration, support during the drug experience and integration sessions following each dosing session.

Study Details

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.

Key Dates

First listed
Sep 12, 2025
Start date
Apr 20, 2026
Status verified
Mar 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Psilocybin with Psychological Support
    This arm will receive two separate doses of psilocybin 25 mg administered four weeks apart, with psychological support, along side treatment as usual. The psychological support includes preparation sessions before, support during, and integration sessions after psilocybin intake.
  • No Intervention: Treatment as Usual
    This arm will receive treatment as usual which includes specialised care offered in an eating disorder unit in Region Skåne, Sweden. If the active treatment arm is determined to be safe, tolerable, and preliminarily effective during the follow-up assessment at 6 months, participants in the control group will have the option to switch to the active treatment while maintaining their usual specialised care.

Primary Outcome Measure

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). [ Time Frame: From enrollment to the end of trial 12 month post-baseline. ]

Central Contacts

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