Psilocybin therapy for anorexia in young adults
Study of Psilocybin for Anorexia in Young Adults
This study is testing if psilocybin therapy can help young adults aged 18 to 25 with severe anorexia feel better and improve their eating habits.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06399263 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of psilocybin therapy to treat refractory Anorexia Nervosa in young adults aged 18 to 25. Participants will undergo a structured treatment regimen that includes preparatory sessions, two psilocybin dosing sessions, and integration sessions aimed at enhancing cognitive flexibility. The study will also involve two family members of each participant to support their treatment process. The effectiveness of the therapy will be assessed by measuring changes in eating disorder symptoms before and after the treatment.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 25 who meet the DSM-5 criteria for Anorexia Nervosa and have not responded to previous treatments.
Not a fit: Patients who do not meet the age criteria or have not experienced persistent symptoms of Anorexia Nervosa after prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for young adults struggling with severe Anorexia Nervosa.
How similar studies have performed: While psilocybin has shown promise in treating various mental health conditions, this specific application for Anorexia Nervosa is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 1 other locations
- University of California, San Francisco — San Francisco, California, United States (Not_yet_recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Marissa Raymond-Flesch, MD — University of California, San Francisco
- Study coordinator: Lisa Fredenburg, MS
- Email: psilocybin.an.study@ucsf.edu
- Phone: 415-993-2486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.