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Trial record 2 of 14 for:    psilocybin | Psilocybin | First posted from 07/30/2018 to 03/21/2020

Effects of Psilocybin in Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052568
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : October 28, 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 exploratory measures related to eating disorder pathophysiology.

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 Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: 1 week post psilocybin session #2 ]
    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.

  2. Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS) [ Time Frame: 1 month post psilocybin session #2 ]
    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: 1 month post psilocybin session #2 ]
    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 post psilocybin session #2 ]
    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: 1 month post psilocybin session #2 ]
    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.



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

General Inclusion Criteria:

  • 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.

General Exclusion Criteria:

  • 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

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    
Other Study ID Numbers: IRB00182516
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 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