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

NCT05035927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Binge Eating Disorder

Interventions

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.

Sponsors & Collaborators

  • TRYP Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jennifer Miller, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2024-03-07
Completion
2024-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05035927 on ClinicalTrials.gov