What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder (BED) include cognitive-behavioral therapy, medications like selective serotonin reuptake inhibitors (SSRIs), and other pharmacological agents such as lisdexamfetamine. Known side effects of SSRIs can include nausea, insomnia, and sexual dysfunction. Lisdexamfetamine may cause dry mouth, insomnia, and increased heart rate. For treatments similar to TRP 8802, which involves psychedelics like psilocybin, side effects can include transient anxiety, nausea, and perceptual changes. These treatments are generally well-tolerated when administered in controlled settings with psychological support.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Binge Eating Disorder (BED). One of the primary treatments is lisdexamfetamine dimesylate (Vyvanse), which is a stimulant that affects neurotransmitters in the brain, including dopamine and norepinephrine. Other treatments include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine (Prozac), which modulate serotonin levels. While there are no FDA-approved psychedelic compounds for BED, the ongoing study of TRP 8802, a psychedelic likely affecting serotonin receptors, represents a novel approach that could potentially offer new therapeutic options for BED by modulating similar pathways.

What other types of research exist?

Promising alternatives to TRP 8802 for Binge Eating Disorder patients include: 1) (R)-9-ethyl-1,3,4,10b-tetrahydro-7-trifluoromethylpyrazino[2,1-a]isoindol-6(2H)-one, a selective 5-HT2C agonist, which has shown efficacy in reducing food intake and body weight in preclinical models. 2) Tetrasubstituted imidazolines, which are potent and selective neuropeptide Y Y5 receptor antagonists, have demonstrated significant reductions in food intake and body weight in animal studies. 3) Naltrexone SR/bupropion SR combination therapy, which has been effective in weight management and could be beneficial for BED patients.

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Psychedelic

Psilocybin + Psychotherapy for Binge Eating Disorder

Phase 2

Waitlist Available

Led By Jennifer Miller, MD

Research Sponsored by TRYP Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 and ≤64 years

Be between 18 and 65 years old

Must not have

Meet DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder

Women who are pregnant or who intend to become pregnant during the study or who are currently nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks following dosing

Awards & highlights

Summary

This trial aims to test the safety of a single dose of TRP 8802, a psychedelic substance, in people with Binge Eating Disorder. The study will see if TRP 8802 can help reduce anxiety and obsessive thoughts about food, potentially improving control over eating behaviors.

Who is the study for?

Adults aged 18-64 with Binge Eating Disorder as per DSM-5 can join this trial. They must not use psychoactive drugs or alcohol for a week before the study and agree to consistent caffeine intake on dosing day. Women should use effective contraception, and men should ensure they do so too.

What is being tested?

The trial is testing TRP-8802 (Psilocybin) combined with psychotherapy for treating Binge Eating Disorder over approximately 5 months. Participants will have preparation sessions, one dose of the drug, integration therapy, and follow-ups.

What are the potential side effects?

While specific side effects are not listed here, psilocybin can typically cause sensory changes, emotional shifts, altered perception of time, nausea, headache or dizziness which usually resolve within hours after ingestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a psychotic disorder, such as schizophrenia, major depression with psychosis, or bipolar disorder.

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I am not pregnant, planning to become pregnant, or nursing during the study.

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I am currently using or might need medication that affects how my body processes drugs.

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I have a significant heart condition or uncontrolled high blood pressure.

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I do not have a stomach or bowel condition that affects medication absorption.

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I have epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks following dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks following dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks following dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the safety of a single dose of TRP 8802 in participants with BED during the TRP 8802 dosing session, and through 12 weeks following dosing

Secondary study objectives

Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on the frequency of binge eating episodes in a BED population through 4 weeks following dosing (i.e., Week 6)

Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on weight-related indicators in a BED population through 4 weeks following dosing (i.e., Week 6)

Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open Label Oral PsilocybinExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychotherapy

2020

Completed Phase 3

~3120

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Binge Eating Disorder (BED) often target serotonin receptors, particularly the 5-HT2A and 5-HT2C subtypes. Medications like lorcaserin, a 5-HT2C receptor agonist, work by enhancing satiety and reducing impulsivity, thereby decreasing binge eating episodes. Psychedelics such as psilocybin, which modulate serotonin receptors, have shown promise in reducing heavy drinking days in alcohol use disorder, suggesting similar benefits for BED by altering mood and behavior patterns. This focus on serotonin pathways is crucial for BED patients as it underscores the potential for more effective and targeted therapies.

Behavioural evidence that d-fenfluramine-induced anorexia in the rat is not mediated by the 5-HT1A receptor subtype.Pimavanserin and Lorcaserin Attenuate Measures of Binge Eating in Male Sprague-Dawley Rats.Therapeutic Potential of 5-HT2C Receptor Agonists for Addictive Disorders.

Who is running the clinical trial?

TRYP TherapeuticsLead Sponsor

3 Previous Clinical Trials

24 Total Patients Enrolled

Jennifer Miller, MDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

TRP-8802 (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05035927 — Phase 2

Binge Eating Disorder Research Study Groups: Open Label Oral Psilocybin

Binge Eating Disorder Clinical Trial 2023: TRP-8802 Highlights & Side Effects. Trial Name: NCT05035927 — Phase 2

TRP-8802 (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05035927 — Phase 2

Binge Eating Disorder Patient Testimony for trial: Trial Name: NCT05035927 — Phase 2

~3 spots leftby Sep 2025

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