Evaluation of Psilocybin in Anorexia Nervosa: Safety & Efficacy

Status Completed

Clinical Trial Summary

The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals, and body weight.

Clinical Trial Description

Because there are no proven treatments that normalize core symptoms in adult anorexia nervosa, a disorder with high chronicity, many individuals seek out alternative approaches to care. Recent evidence has suggested that anxiety, obsessive compulsive disorder, and diminished reward or motivation play key roles in the development and maintenance of dysfunctional eating, and poor outcome. In recent years, a growing number of studies have demonstrated the safety and preliminary efficacy of psilocybin in clinical trials for a range of psychiatric illnesses including treatment resistant depression, obsessive compulsive disorder, addiction, and anxiety. Psilocybin may represent a promising new treatment for anorexia nervosa. However, no studies have tested psilocybin in this eating disorder population. Accordingly, this study aims to establish the safety, tolerability and dosing of psilocybin in adult patients with anorexia nervosa, as well as gather pilot data on possible efficacy. For this study, the investigators will recruit adults who currently have a DSM-V diagnosis of anorexia nervosa. Participants will undergo medical and psychological screening and those who are deemed eligible will partake in a maximum of 7 study visits, lasting from 4-8 weeks. On dosing day, participants will receive a single 25 mg dose of psilocybin along with psychotherapeutic support, which includes preparation and integration sessions surrounding the experience. There will be a follow-up period of one month following the psilocybin session during which a range of psychological measures (questionnaires and interviews) will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04661514
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Completed
Phase	Phase 2
Start date	May 1, 2021
Completion date	June 10, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05531604` - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation	`NCT04174703` - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing	N/A
Active, not recruiting	`NCT04883554` - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study	N/A
Recruiting	`NCT04213820` - TMS and Body Image Treatment for Anorexia Nervosa	N/A
Completed	`NCT03414112` - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa	Early Phase 1
Recruiting	`NCT06144905` - Norwegian Microbiota Study in Anorexia Nervosa
Recruiting	`NCT05803707` - Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study	N/A
Not yet recruiting	`NCT06380257` - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting	`NCT05632497` - Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
Not yet recruiting	`NCT05682417` - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa	N/A
Not yet recruiting	`NCT04804800` - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa	N/A
Not yet recruiting	`NCT03600610` - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa	N/A
Completed	`NCT02745067` - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa	N/A
Completed	`NCT02382055` - Changing Habits in Anorexia Nervosa: Novel Treatment Development	N/A
Completed	`NCT03075371` - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa	N/A
Terminated	`NCT02240797` - Kappa Opioid Receptor Imaging in Anorexia	N/A
Completed	`NCT03144986` - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa	N/A
Unknown status	`NCT01761942` - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa	Phase 2
Completed	`NCT02551445` - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.	N/A
Completed	`NCT01579682` - Adaptive Family Treatment for Adolescent Anorexia Nervosa	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms