Magic mushroom therapy targets anorexia in young adults
NCT ID NCT06399263
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether psilocybin, a psychedelic substance, can help young adults aged 18-25 with hard-to-treat anorexia nervosa. Participants receive two doses of psilocybin along with therapy sessions, and family members are also involved. The goal is to see if psilocybin increases mental flexibility and reduces eating disorder symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to understand and provide informed consent. * Between 18 and 25 years old at time of screening. * Meets Diagnostic and Statistical Manual (DSM-5) criteria for any type of Anorexia Nervosa * Currently experiencing symptoms of Anorexia Nervosa * Comfortable reading and writing in English * Have no anticipated changes in medication or surgical procedures for trial duration * Commit to attend all in-person and remote study visits and participate in all data collection procedures * Able to identify one or two family members or close friends to co-enroll in the study, who will be required to participate in select therapy sessions. * Agree to use a highly effective form of contraception for two weeks prior to starting the study and one month after finishing the study. * Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals. * Agree to consume approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions. If the young adult participant does not routinely consume caffeinated beverages, they must agree not to do so prior to psilocybin administration sessions. Exclusion Criteria: * Current known pregnancy or positive pregnancy test at any time during the study * Personal history of bipolar disorder, or psychotic disorder verified by the Structured Clinical Interview for DSM-5 (SCID) and medical history at screening * Body Mass Index less than 12 at screening * Unstable vital signs including Blood Pressure, Heart Rate, or Temperature * Abnormal Safety Labs including sodium, potassium, magnesium, phosphorus, creatinine, estimated Glomerular Filtration Rate, Aspartate Transferase, Alanine Transaminase * Electrocardiogram abnormalities * Hospitalization or participation in a residential program for more than 2 of the past 4 weeks at the time of screening. * Unwilling to abstain from alcohol, Cannabidiol (CBD), tetrahydrocannabinol (THC), marijuana, and illicit drug use for 48 hours pre and post psilocybin dosing days and abstain from nicotine for 10 hours pre and post psilocybin dosing. * Positive urine toxicology testing for amphetamines, benzodiazepines, cocaine, cannabis, 3,4-Methylenedioxymethamphetamine (MDMA), and opioids (including methadone and buprenorphine) on the morning of either psilocybin administration session. * History of cardiovascular disease * Uncontrolled endocrine conditions, including diabetes, hyper or hypothyroidism * Significant and uncontrolled gastrointestinal illness at the discretion of the investigator * Significant and uncontrolled neurological disease including uncontrolled seizure disorder at the discretion of the investigator * Use of any prohibited concomitant medications or inability or unwillingness to discontinue according to the study's prescribed medication taper or tapering with the participants primary prescriber. * Needle phobia. * Simultaneous enrollment in another clinical trial. * Pregnant or Breast feeding. * Allergy or intolerance to any of the materials contained in the drug product * History of severe reaction to psychedelics at the discretion of the investigators. * High risk of self-harm/suicide * Mental health condition that will prevent engagement with the treatment team. * Unwilling or unable to participate in the treatment protocol as planned, including hydration with sports drinks on dosing days. * If any study physician feels that it would be unsafe to continue for any mental, physical or other reason
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94107, United States
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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- Can a parent support group help teens with both autism and anorexia?
- Lab-Grown brain cells could unlock Anorexia's secrets
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