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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks following dosing
Awards & highlights
Study Summary
This trial will assess the safety and feasibility of using TRP 8802 to treat Binge Eating Disorder.
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 64 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks following dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks following dosing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Binge Eating Disorder according to the DSM-5 criteria.You have had thoughts of hurting yourself or have engaged in self-harming behaviors in the past year, or the doctor believes you are at high risk for suicide based on their evaluation.You have close family members who have experienced severe mental health issues like psychosis.I agree to not take any non-prescribed drugs or supplements for a week before the drug session, except when allowed.I have been diagnosed with a psychotic disorder, such as schizophrenia, major depression with psychosis, or bipolar disorder.I am not pregnant, planning to become pregnant, or nursing during the study.I am currently using or might need medication that affects how my body processes drugs.You need to avoid using any drugs that affect your mood or alcohol for at least a week before taking the study drug.I have a significant heart condition or uncontrolled high blood pressure.I am using or agree to use effective birth control during and after the study.I do not have a stomach or bowel condition that affects medication absorption.I have epilepsy.I am currently taking medication or supplements that affect serotonin levels.My doctor considers my health stable based on recent exams and tests.I am a man who can father children and will use contraception for 90 days after my last dose.I agree not to use any psychoactive drugs or alcohol for at least 1 week before taking the trial drug.I am between 18 and 64 years old.You have experienced negative reactions or side effects from psilocybin in the past.You have a serious problem with alcohol or drugs, as defined by specific criteria in the DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label Oral Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Binge Eating Disorder Patient Testimony for trial: Trial Name: NCT05035927 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I possibly qualify to take part in this experiment?
"Around 10 people will be admitted to this clinical trial. To qualify, participants must have hyperphagia and between the ages of 18-64."
Answered by AI
Is this research project available to patients who are younger than 45 years old?
"The age range for patients that can enroll in this clinical trial is 18 to 64 years old. If a patient falls outside of this age bracket, there are 50 other trials for people under the age of 18 and 90 for seniors above the age of 65."
Answered by AI
What is the total amount of people who can enroll in this clinical trial?
"The clinical trial is actively recruiting patients, with 10 needed from 1 location. The listing on clinicaltrials.gov shows that the trial was posted on 3/16/2022 and edited on 4/27/2022."
Answered by AI
Has Psychotherapy been cleared by the FDA?
"While there is some evidence that this intervention is safe, it is only supported by data from a Phase 2 trial. As such, the team has given it a score of 2."
Answered by AI
Do we have any other options for treatment besides Psychotherapy?
"Currently, 37 different Psychotherapy studies are underway. 0 of those active studies have reached Phase 3 clinical trials. Most of the research is based in Vancouver, Washington; however, there are 40 locations conducting this type of research."
Answered by AI
Are we still enrolling participants for this research project?
"The trial, as detailed on clinicaltrials.gov, is currently looking for volunteers. The posting went up on 3/16/2022 and has been edited most recently on 4/27/2022."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
North Carolina
Other
Florida
How old are they?
18 - 65
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am very interested in psilocybin as an effective treatment. I have struggled all of my life with food. I use it to cope with emotions. I use it when I’m bored. I have been on every diet known to man but nothing seems to keep me I accountable. I will eat in secret, hide the evidence, and act like nothing happened and go about my regular meals. I’m just so tired of feeling out of control. I am willing to try anything. I have heard remarkable anecdotal stories about experiences with psilocybin and I’m just hoping it can work for me too.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How often would I need to visit? Do I have to pay to be apart of the trial? Can I be a part of the trial without health insurance?
PatientReceived 2+ prior treatments
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