Effects of Psilocybin in Anorexia Nervosa

NCT04052568 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00182516
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Change in Hospital Anxiety and Depression Scale (HADS) Score

  The HADS is a 14-item self-report questionnaire that assesses both anxiety (7 questions) and depression (7 questions). Each question is scored on a 4-point Likert scale from 0-3, with higher scores indicating more severe symptoms.

  1 week post final psilocybin session

• Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS)

  This is a 40-item self-report measure of health related quality of life that is specifically developed for eating disorder populations. Each question is rated on a 5 point scale from 1-5, with higher scores indicating better quality of life.

  2 months post final psilocybin session

Secondary Outcomes (4)

• Change in Eating Disorder Examination Questionnaire (EDE-Q) score

  1 month post final psilocybin session

• Change in Eating Disorder Examination (EDE) score

  1 month post final psilocybin session

• Change in Body mass index (BMI)

  3 months post final psilocybin session

• Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score

  1 month post final psilocybin session

Study Arms (1)

Experimental psilocybin

EXPERIMENTAL

Participants will have up to four doses of psilocybin.

Drug: Psilocybin

Interventions

Psilocybin DRUG

Participants will undergo up to four moderate to high dose psilocybin sessions. Dosing at the first session will be 20 mg. For subsequent sessions participants will either remain at their previous dose, or increase by increments of 5 mg up to a maximum of 30 mg.

Experimental psilocybin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and have a history of AN for at least 3 years prior to screening
• Have at least one prior attempt at treatment
• Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (complete blood count, comprehensive metabolic panel, urine pregnancy test, urine toxicology screen).
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.

You may not qualify if:

• Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of childbearing potential and sexually active who are not practicing an effective means of birth control.
• Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve, or transient ischemic attack in the past year. Resting heart rate may be no less than 50 beats per minute unless cleared by a cardiologist.
• Epilepsy with history of seizures
• Type 1 diabetes
• First degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
• Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Roland Griffiths, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Study Start: August 26, 2019
• Primary Completion: January 5, 2022
• Study Completion: April 20, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)