Actively Recruiting
Study of Psilocybin for Anorexia in Young Adults
Led by Marissa Raymond-Flesch, MD, MPH · Updated on 2026-03-03
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of psilocybin therapy to treat young adults aged 18 to 25 with refractory Anorexia Nervosa. This phase 2 trial aims to assess whether psilocybin can improve cognitive flexibility, which may lead to long-term changes in rigid thinking and habitual eating and exercise behaviors. Family members will also be involved to support participants through the therapy process. The treatment involves multiple sessions including three preparatory sessions, a first psilocybin dose of 20 mg, two integration sessions, a second psilocybin dose of up to 25 mg, and four final integration sessions. One to two family members or close friends will co-enroll, attending parts of the preparatory and integration sessions to receive psychoeducation on supporting the participant. Participants will be assessed on eating disorder symptoms using the Eating Disorder Examination at baseline, 28 days, 90 days, and one year after treatment begins. The study requires commitment to both in-person and remote visits, adherence to medication and supplement restrictions before dosing, and family involvement. Safety monitoring and data collection will continue throughout the study period, which is expected to last until November 2029.
CONDITIONS
Brief Title
Study of Psilocybin for Anorexia in Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions
You will not qualify if you...
- 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 screening
- Unwilling to abstain from alcohol, CBD, 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 test for amphetamines, benzodiazepines, cocaine, cannabis, MDMA, and opioids on dosing days
- History of cardiovascular disease
- Uncontrolled endocrine conditions including diabetes, hyper or hypothyroidism
- Significant and uncontrolled gastrointestinal illness at investigator discretion
- Significant and uncontrolled neurological disease including uncontrolled seizure disorder at investigator discretion
- Use of any prohibited medications or inability/unwillingness to discontinue as prescribed
- Needle phobia
- Simultaneous enrollment in another clinical trial
- Pregnant or breast feeding
- Allergy or intolerance to any materials in the drug product
- History of severe reaction to psychedelics at investigator discretion
- High risk of self-harm or suicide
- Mental health condition preventing engagement with treatment team
- Unwilling or unable to participate in treatment protocol as planned
- Investigator judgment of safety concerns due to mental, physical, or other reasons
Research Team
L
Lisa Fredenburg, MS
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