NCT06399263 · Marissa Raymond-Flesch, MD, MPH
Study of Psilocybin for Anorexia in Young Adults
(SPANYA)
What this study is about
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 30mg), and four final integration sessions. Eating disorder symptoms will be measured pre and post treatment.
View original scientific description
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 30mg), and four final integration sessions. Eating disorder symptoms will be measured pre and post treatment. Two family members of each young adult participant will be enrolled in the study.
Interventions
DRUG
Psilocybin
The psilocybin will include two dose administration sessions, first a 20mg administration, and second an administration of up to 25mg.
BEHAVIORAL
Preparation and Integration Sessions
The psilocybin therapy will include three preparatory sessions, two dose A integration sessions, and four final integration sessions.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Persistence of Anorexia Nervosa diagnosis after at least one attempt of eating disorder focused treatment or higher level of care
- 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. The co-enrolled family member and/or another non-enrolled family member must be willing and able to pick them up and stay with them overnight on dosing days.
- Agree to use a highly effective form of contrac
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations