Effects of Psilocybin in Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT04052568 |
Recruitment Status :
Completed
First Posted : August 12, 2019
Last Update Posted : May 6, 2023
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
Tracking Information | |||||
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First Submitted Date ICMJE | August 8, 2019 | ||||
First Posted Date ICMJE | August 12, 2019 | ||||
Last Update Posted Date | May 6, 2023 | ||||
Actual Study Start Date ICMJE | August 26, 2019 | ||||
Actual Primary Completion Date | January 5, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of Psilocybin in Anorexia Nervosa | ||||
Official Title ICMJE | Effects of Psilocybin in Anorexia Nervosa | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Anorexia Nervosa | ||||
Intervention ICMJE | Drug: Psilocybin
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.
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Study Arms ICMJE | Experimental: Experimental psilocybin
Participants will have up to four doses of psilocybin.
Intervention: Drug: Psilocybin
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE |
18 | ||||
Actual Study Completion Date ICMJE | April 20, 2023 | ||||
Actual Primary Completion Date | January 5, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | General Inclusion Criteria:
General Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04052568 | ||||
Other Study ID Numbers ICMJE | IRB00182516 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Johns Hopkins University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||
Verification Date | May 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |