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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05035927
Recruitment Status : Not yet recruiting
First Posted : September 5, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
TRYP Therapeutics

Tracking Information
First Submitted Date  ICMJE August 24, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date January 6, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
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 [ Time Frame: 12 weeks following dosing ]
Safety assessments will be conducted to monitor AEs, including SAEs, protocol specific safety laboratory assessments, protocol specific vital signs and other tests/questionnaires that are deemed crucial to the safety evaluation of the study. Planned timing for all safety assessments is provided in the SOA.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2021)
  • Body Mass Index [ Time Frame: 8 weeks following the second dose ]
    Patient's weight in kilograms divided by the square of height in meters. Patient will be weighed on a scale and measured with a stadiometer
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 8 weeks following the second dose ]
    The Clinician's overall impression of a patient's condition (CGI-Improvement, CGI-I, rated 1-7 from "normal" to "among the most extremely ill" and change over the duration of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
  • Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population. [ Time Frame: 12 weeks following dosing ]
    Magnitude and duration of TRP 8802-induced dissociative effects in participants with BED using the MEQ30 and MRS
  • 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) [ Time Frame: 6 Weeks ]
    Frequency of binge eating episodes as measured by a modified Eating Questionnaire
  • 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) [ Time Frame: 6 Weeks ]
    Waist Circumference and BMI
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder
Official Title  ICMJE A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder
Brief 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Binge Eating Disorder
Intervention  ICMJE
  • 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.
    Other Name: Psilocybin
  • 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.
Study Arms  ICMJE Experimental: Open Label Oral Psilocybin
Interventions:
  • Drug: TRYP-0082
  • Behavioral: Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2021)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion/Exclusion Criteria: Inclusion Criteria:

To participate in this study, subjects will have to meet all of the following criteria:

  1. Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for BED.
  2. Age ≥18 and ≤64 years.
  3. Provision of signed and dated informed consent form.
  4. Stated willingness to comply with all study procedures and availability for the duration of the study.
  5. Medically stable in the judgment of the Principal Investigator, as determined by screening medical, physical examination, ECG, and routine laboratory tests including blood and urinalysis.
  6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks following the dose of TRP 8802. Adequate birth control methods include intrauterine device; injected, implanted, intravaginal, or transdermal hormonal method; oral hormones plus a barrier contraception; abstinence; vasectomized sole partner; or double barrier contraception.
  7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner through 90 days post-dose.
  8. Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the dosing session day.
  9. Agree to refrain from using any psychoactive drugs, including alcoholic beverages for a minimum of 1 week prior to drug administration.
  10. Agree that for 1 week before the drug session, including the morning of the session, he/she will refrain from taking any nonprescription medication, nutritional supplement, herbal supplement, or as needed (PRN) prescription medication except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals and contraceptives.

Exclusion Criteria:

To participate in this study, subjects must not meet any of the following criteria:

  1. Significant suicide risk as defined by either suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening, or at Baseline; or suicidal behaviors within the past year; clinical assessment of significant suicidal risk during subject interview.
  2. Participation in another concurrent clinical study or within the preceding month.
  3. Women who are pregnant or who intend to become pregnant during the study or who are currently nursing.
  4. Vital signs, averaged over 3 readings within 15 minutes, of systolic blood pressure (BP) >139 mm Hg, diastolic BP >89 mm Hg, or heart rate >90 bpm.
  5. Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, QTc >450 msec at screening, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition.
  6. Presence of a gastrointestinal disease that could interfere with absorption of orally-administered TRP 8802.
  7. Have epilepsy.
  8. 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.
  9. Family history of psychosis.
  10. Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder.
  11. Positive urine drug screen or alcohol breath test at screening. A repeat test can be conducted at screening or Day -1 at the discretion of the Principal Investigator or delegate.
  12. Prior adverse effects from psilocybin.
  13. Currently taking or expected to need prior to the dosing session, UGT1A9 or 1A10 inhibitors (e.g., regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasirox, ginseng) and aldehyde or alcohol dehydrogenase inhibitor (e.g., disulfiram).
  14. Currently taking or testing positive on urine drug screen, drugs of abuse such as amphetamines, buprenorphine, benzodiazepines, cocaine, methamphetamines, Ecstasy (MDMA), morphine, methadone, oxycodone, marijuana, ethyl glucuronide, fentanyl, tramadol, and synthetic cannabinoids (K2).
  15. Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including SSRIs, MAOIs, or serotonin-acting dietary supplements (such as 5 hydroxy tryptophan or St. John's wort). For individuals who have intermittent or PRN use of such medications, the dosing session will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  16. fMRI subjects: Contraindications to fMRI procedures, per institutional policy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jim Gilligan, PhD (833) 811-8797 jgilligan@tryptherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035927
Other Study ID Numbers  ICMJE TRYP-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TRYP Therapeutics
Study Sponsor  ICMJE TRYP Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Miller, MD University of Florida
PRS Account TRYP Therapeutics
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP