Anorexia NervosaPhase 2SPANYANCT06399263
Study of Psilocybin for Anorexia in Young Adults
A Phase 2 study testing Psilocybin and Preparation and Integration Sessions in people with Anorexia Nervosa, run by Marissa Raymond-Flesch, MD, MPH at 2 sites in United States.
Trial summary
This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Psilocybin and Preparation and Integration Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2024to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94107
Lisa Fredenburg, MS, psilocybin.an.study@ucsf.edu
Marissa Raymond-Flesch, M.D.
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
About this study
This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be measured pre and post treatment. One to two family member(s) of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.
- Conditions
- Anorexia Nervosa
- Being tested
- Psilocybin, Preparation and Integration Sessions
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called PEX010
The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg.
Preparation and Integration SessionsBehavioural
Also called Psilocybin Therapy
The psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Therapy | Experimental | The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and four final integration sessions Receives: Drug: Psilocybin; Behavioral: Preparation and Integration Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination (EDE)
The EDE assess eating disorder behaviors and attitudes though an interviewer administered questionnaire. It provides 4 subscale scores (Restraint, Eating Concern, Shape Concern and Weight Concern). Score range from 0 to 6 and are averaged to calculate a global score. Higher scores indicate increased eating disorder thoughts and behaviors.
Measured: Baseline, 28 days, 90 days, 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start18 Nov 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marissa Raymond-Flesch, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marissa Raymond-Flesch, MD, MPH, University of California, San Francisco
- Investigators
- Marissa Raymond-Flesch, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399263
- Sponsor's protocol ID
- 23-39236
- Acronym
- SPANYA
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psilocybin for Anorexia in Young Adults
- ClinicalTrials.gov ID
- NCT06399263
- Acronym / sponsor ID
- SPANYA / 23-39236
- Conditions
- Anorexia Nervosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marissa Raymond-Flesch, MD, MPHUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be measured pre and post treatment. One to two family member(s) of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Therapy | Experimental | Drug: Psilocybin, Behavioral: Preparation and Integration SessionsThe psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and four final integration sessions |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: PEX010The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg. | Drug | Psilocybin Therapy |
| Preparation and Integration SessionsAlso: Psilocybin TherapyThe psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions. | Behavioural | Psilocybin Therapy |
Primary outcome
Eating Disorder Examination (EDE)
Time frame: Baseline, 28 days, 90 days, 365 days
The EDE assess eating disorder behaviors and attitudes though an interviewer administered questionnaire. It provides 4 subscale scores (Restraint, Eating Concern, Shape Concern and Weight Concern). Score range from 0 to 6 and are averaged to calculate a global score. Higher scores indicate increased eating disorder thoughts and behaviors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marissa Raymond-Flesch, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin and Preparation and Integration Sessions in people with Anorexia Nervosa, run by Marissa Raymond-Flesch, MD, MPH at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Fredenburg, MS (415-993-2486, psilocybin.an.study@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination (EDE) (time frame: Baseline, 28 days, 90 days, 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.