Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
|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: NCT04505189|
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: Psilocybin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||All participants will receive 3 doses of psilocybin. The maximum dose a participant will receive in a single session is 25 mg.|
|Official Title:||Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
Psilocybin assisted psychotherapy
- Readiness and Motivation Questionnaire (RMQ) [ Time Frame: Baseline - Primary endpoint (6 weeks) ]Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology.
- Eating Disorder Examination (EDE) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]Decrease in eating disorder psychopathology.
- Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: Baseline - Primary endpoint (6 weeks) - 6 month follow-up. ]Decrease in eating disorder psychopathology.
- Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Baseline - Primary endpoint (6 weeks) ]Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks.
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): NCT04505189
|Contact: Meg J Spriggs, PhD||+44 firstname.lastname@example.org|
|Imperial College Hammersmith campus||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Meg Spriggs, Dr email@example.com|