Clinical Trials Logo

Clinical Trial Summary

To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP 8802 among individuals with Binge Eating Disorder. This is a single-center phase 2a open-label study to assess the safety and feasibility of a single dose of TRP 8802 in subjects with BED. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 12 weeks following the dose of TRP 8802. The total participation in the study will be up to approximately 5 months.


Clinical Trial Description

Binge eating disorder is the most common eating disorder and is associated with obesity and psychiatric comorbidities, including depression, and impulsive and compulsive disorders. Binge eating disorder is marked by severe disturbance to a person's control over their eating behaviors and high anxiety around food. Various programs using psilocybin paired with psychotherapy have shown positive effects in treating a variety of psychiatric and behavioral conditions, including cancer-related psychiatric distress, anxiety, treatment-resistant depression, and nicotine and alcohol addiction. Based on clinical precedents, relevant neuropharmacology, and mechanistic similarities, psilocybin is theorized to have the potential to be part of the treatment of overeating disorders. TRP-8802 could accomplish this by moderating overall anxiety, anxiety around food, perseveration, and repetitive and intrusive thoughts about food in people with BED. The primary objective of this study is to: 1. Assess the safety of a single dose of TRP 8802 in participants with binge eating disorder (BED) during the TRP 8802 dosing session, and through 12 weeks following dosing (i.e., Week 14). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05035927
Study type Interventional
Source TRYP Therapeutics
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 16, 2022
Completion date August 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT02978742 - Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder N/A
Recruiting NCT02659488 - Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects Phase 2
Completed NCT02659475 - Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED) Phase 2
Completed NCT00601653 - Effectiveness of Cognitive Behavioral Therapy Plus Nutritional Counseling in Promoting Weight Loss in People With Binge Eating Disorder N/A
Completed NCT02834299 - Dialectical Behavior Therapy Guided Self-Help for Binge Eating Disorder N/A
Completed NCT02553824 - FDA Approved Medication to Reduce Binge Eating and/or Purging Phase 1
Completed NCT02564588 - Dasotraline Binge Eating Disorder Study Phase 2/Phase 3
Completed NCT00307190 - Hormone Release and Stomach Disturbances in People With Binge Eating Disorder N/A
Completed NCT01718483 - SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT01718509 - SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT02503098 - Optimizing a Smartphone Application for Individuals With Eating Disorders N/A
Active, not recruiting NCT01837953 - Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial N/A
Completed NCT01010789 - Armodafinil in Binge Eating Disorder (BED) Phase 3
Completed NCT01098435 - ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder Phase 2
Completed NCT01552759 - Appetite Hormones in Binge Eating Disorder N/A
Completed NCT00330655 - An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder Phase 4
Completed NCT01291173 - Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder Phase 2
Completed NCT03107026 - A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder Phase 3
Completed NCT02079935 - Treatment of Eating Disorders by Physical Activity and Nutrition Counseling N/A
Completed NCT00277641 - Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity Phase 3