Clinical TrialEating DisordersPsilocybinCompleted

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events, vital signs, ECGs and laboratory tests; secondary aims explore symptoms, body image, anxiety and weight (n=16).

Target Enrollment
16 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Single-group, open-label interventional study in adults (18–40 years) with DSM‑5 anorexia nervosa evaluating one 25 mg oral dose of psilocybin given with preparatory and integration psychotherapy; dosing session lasts approximately 4–6 hours.

Outcomes focus on safety and tolerability (AEs, vitals, ECG, labs) with exploratory efficacy measures for eating‑disorder symptoms, body image, anxiety, food‑related obsessions and rituals, and body weight over a one‑month follow‑up.

Study Protocol

Preparation

sessions

Dosing

1 sessions
360 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Single-group psilocybin-assisted psychotherapy: one 25 mg oral dose administered with preparatory and integration therapy support.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg given as 5×5 mg oral capsules; lead and assisting therapist present; administration session ~4–6 hours.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. 18 to 40 years of age at Screening
  • 2. Current diagnosis of Anorexia Nervosa (informed by DSM 5) based on medical records, clinical assessment, weight, and documented completion of the version 7.0.2 Mini International Neuropsychiatric Interview (MINI)
  • 3. Agree for the study team to maintain contact with their primary care team for the duration of the study.
  • 4. Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

Exclusion Criteria

  • Exclusion Criteria:
  • Medical exclusion criteria will be determined during the Screening Period and Baseline. Exclusion assessments that will be rechecked on the day of dosing are marked with an Asterix.
  • 1. BMI < 16 kg/m2 *
  • 2. Medical instability as indicated by significant (>3kg) weight loss during the screening period, orthostatic heart rate and blood pressure *
  • 3. Women who are pregnant, nursing, or planning a pregnancy in the near future. Male and female participants who are sexually active must agree to use a highly effective contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening visits and Baseline, and psilocybin dosing session days *
  • 4. Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
  • 5. Uncontrolled or insulin-dependent diabetes.
  • 6. Seizure disorder.
  • 7. Use of psychedelics, including psilocybin, within one year prior to Screening assessment
  • 8. Positive urine drug screen for illicit drugs or drugs of abuse in the Screening Period and Baseline and psilocybin dosing days. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion *
  • 9. Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening
  • 10. Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening, such as liver function tests (LFTs) three times greater than the upper limit of normal, reduced glomerular filtration rate (GFR) and elevated creatinin two times of upper limit of normal
  • 11. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
  • 12. Non-English speakers
  • 13. Current or past history of schizophrenia, psychotic disorder, bipolar disorder, significant history of mania, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder as assessed by medical history and a structured clinical interview
  • 14. McLean Screening Instrument for Borderline Personality Disorder >7 at Screening
  • 15. Currently taking a serotonergic medication. All serotonergic medication must be discontinued at least two weeks prior to Baseline.
  • 16. Current (within the last year) alcohol or substance use disorder as informed by DSM-5 at Screening
  • 17. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview (pre-treatment Baseline sessions).
  • 18. Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current episode.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment16 participants
  • Timeline
    Start: 2021-05-01
    End: 2022-06-10
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Altman Clinical and Translational Research Institute — La Jolla, California, United States

Your Library