A Phase 1, Open-label, Pilot Study to Assess the Safety, Feasibility and Initial Efficacy of IV infused Psilocin (TRP-8803) Administration in Concert with Psychotherapy Among Adult Patients with Binge Eating Disorder (BED)

This Phase I open-label trial (n=12) will investigate the safety, feasibility, and initial efficacy of intravenous psilocin (TRP-8803), administered in two doses (ranging from 6.7 mg to 15 mg) in combination with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).

Conducted as part of the BED-IV study, this pilot trial is a follow-up to earlier research and will explore the therapeutic effects of psilocin when paired with structured psychotherapy. Participants will undergo three preparatory psychotherapy sessions before their first intravenous dose of psilocin, followed by two integration sessions. A second dosing session will be held two weeks later, with three further integration sessions. Dosing regimens vary between cohorts, with infusion protocols such as 5 mg loading plus 6.7 mg maintenance over 60 minutes, or higher-dose options reaching 15 mg over extended durations.

The trial aims to assess safety through clinical monitoring, physical exams, lab tests, and tracking adverse events. Secondary outcomes include changes in binge eating frequency, body mass index, mood, body image, quality of life, and neurobiological markers such as EEG, MRI, and metabolic hormones (e.g., leptin, ghrelin, insulin). The study also measures participants’ subjective psychedelic experiences to better understand therapeutic mechanisms. The psychotherapy model is delivered by qualified dyads trained in psychedelic-assisted therapy, and focuses on preparation, non-directive support during dosing, and integration.

Topic Eating Disorders Safety
Compound Psilocybin
Country Australia
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Sponsors & Collaborators

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

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