NCT05035927

Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder

A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: TRYP Therapeutics · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	TRYP-0082	A single (1) 25 mg oral dose of TRP 8802 will be administered in a carefully monitored setting following 6 to 8 hours of preparatory psychotherapy. Subjects will be in the study for 12 weeks following the dose of TRP 8802 (until Week 14), approximately 5 months from initiation of screening through the last follow-up.
BEHAVIORAL	Psychotherapy	A single (1) 25 mg oral dose of TRP 8802 will be administered in a carefully monitored setting following 6 to 8 hours of preparatory psychotherapy. Subjects will be in the study for 12 weeks following the dose of TRP 8802 (until Week 14), approximately 5 months from initiation of screening through the last follow-up.

Timeline

• Start date: 2022-03-16
• Primary completion: 2024-03-07
• Completion: 2024-06-07
• First posted: 2021-09-05
• Last updated: 2024-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study