Study of Psilocybin for Anorexia in Young Adults (SPANYA)
Single-group interventional Phase II study (n=40) of psilocybin therapy for refractory Anorexia Nervosa in young adults with two dosing sessions (20 mg then up to 30 mg) plus preparatory and integration therapy.
Detailed Description
Single-site, single-group Phase II study evaluating psilocybin therapy for refractory Anorexia Nervosa in young adults (18–25 years).
Intervention includes three preparatory therapy sessions, two psilocybin dosing sessions (first 20 mg, second up to 30 mg) and a total of six integration sessions; selected family members co-enrol and attend portions of sessions for psychoeducation and support.
Outcomes assess eating-disorder symptoms pre- and post-treatment and test the hypothesis that increases in cognitive flexibility predict long-term reductions in cognitive rigidity, habitual eating, and exercise behaviours.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Psilocybin Therapy
experimentalThree preparatory sessions; two psilocybin dosing sessions (20 mg then up to 30 mg) with intermediate and final integration sessions; family-member co-enrolment for selected sessions and psychoeducation.
Interventions
- Psilocybin20 - 30 mgvia Oral• two dosing sessions• 2 doses total
First session 20 mg; second session up to 30 mg.
- Compoundvia Other• therapy sessions
Preparation and integration therapy (3 preparatory; 2 integration after first dose; 4 final integration). Family member(s) co-enrolled to attend portions of sessions and receive psychoeducation.
Participants
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 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.
Study Details
- StatusRecruiting
- PhasePhase II
- Typeinterventional
- DesignNon-randomized
- Target Enrollment40 participants
- TimelineStart: 2024-06-01End: 2029-06-30
- Compound
- Topic