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Effects of Psilocybin in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04052568
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 secondary measures as described below.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Psilocybin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Psilocybin in Anorexia Nervosa
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Experimental psilocybin
Participants will have two sessions of psilocybin treatment.
Drug: Psilocybin
Participants will undergo two moderate to high dose psilocybin sessions. Dosing at the first session will be the lesser of 20 mg or 0.6 mg/kg. For the second session participants will either remain at participants' initial dose, or increase to the lesser of 25 mg or 0.6 mg/kg at the discretion of the study team.




Primary Outcome Measures :
  1. Change in the State-Trait Anxiety Inventory (STAI) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    The STAI is a 40-item self-report scale that measures both state and trait anxiety. Scores either component range from 20 to 80 with a higher score indicating higher levels of anxiety.

  2. Change in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    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.

  3. Change in Beck Depression Inventory (BDI) Score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    The BDI is a 21-item self-report scale, rating severity of depressive symptoms on a 4-point Likert scale ranging from 0-3. Total scores range from 0-63 with higher scores indicating higher levels of depressive symptoms.

  4. Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS) [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months after second psilocybin session ]
    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.


Secondary Outcome Measures :
  1. Change in Eating Disorder Examination Questionnaire (EDE-Q) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]
    This is a 28-item self-report score that measures severity of eating disorder symptoms across four domains that each make up a sub-scale: dietary restraint, eating concern, weight concern, and shape concern. A global score is calculated by averaging sub-scale scores. Sub-scale and global scores range from 0-6 with higher scores indicating higher severity.

  2. Change in Body mass index (BMI) [ Time Frame: 3 months ]
    This is a measure of body mass calculated from height and weight (Kg/m^2).

  3. Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score [ Time Frame: Baseline, 1 week, and 1, 2, 3, and 6 months post second psilocybin session ]
    The ANSOCQ is a 20-item self-administered questionnaire that places respondents in one of the five stages of change based on Prochaska and DiClemente's model. The maximum raw score is 100, with higher scores indicating higher levels of motivation. An overall classification of the stage of change is obtained by dividing the raw score by 5.

  4. Change in Food preference as assessed by food choice task [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]
    The investigators will assess food preference using a validated food choice task in which participants are shown images of a variety of food items and are asked to rate the subjective healthiness and tastiness of each item.

  5. Change in Food preference as assessed by the Geiselman Food Preference Questionnaire (FPQ) [ Time Frame: Baseline, 1 and 6 months post second psilocybin session ]
    The Geiselman Food Preference Questionnaire is a validated questionnaire that assesses preference for a variety of foods on a 9-point Likert scale with higher scores indicating higher preference. From these responses, a fat preference score is calculated from responses with a score of <100 indicating below average fat preference, and scores >100 indicating above average fat preference.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently meet criteria for AN restricting subtype by Diagnostic and Statistical Manual 5th edition (DSM-5) criteria, and reports a history of AN for at least 3 years prior to screening
  • Have a screening BMI ≥16 and ≤19 kg/m2 and report being unable to maintain a BMI >19 kg/m2 for more than 12 consecutive months during the past 3 years
  • Have at least one prior attempt at treatment, defined as at least 12 sessions of outpatient treatment or one inpatient admission to a behavioral specialty program.
  • No antidepressant medications for approximately 5 half-lives prior to enrollment
  • Be judged by study team clinicians to be at low risk for suicidality
  • Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study
  • 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 consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
  • Agree not to take any pro re nata (PRN) medications on the mornings of drug sessions
  • Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
  • Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
  • Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)

Exclusion Criteria:

  • Chronic purging behaviors such as vomiting, laxative or diuretic abuse (twice a week or more in the past 3 months). Significantly elevated bicarbonate level or low chloride and/or potassium not explained by another medical condition would constitute evidence of such behavior and be exclusionary.
  • 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
  • Currently taking on a regular (e.g., daily) basis any psychoactive prescription medication or any medications having a primary centrally-acting serotonergic effect. For individuals who have intermittent or as needed use of such medications, psilocybin sessions will not be conducted until approximately 5 half-lives of the agent have elapsed after the last dose.
  • Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder
  • Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco and caffeine)
  • Have a 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052568


Contacts
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Contact: Natalie Gukasyan, M.D. 410-550-2253 gukasyan@jhmi.edu

Locations
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United States, Maryland
Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Natalie Gukasyan, M.D.    410-550-2253      
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Roland Griffiths, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04052568     History of Changes
Other Study ID Numbers: IRB00182516
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs