Binge Eating DisorderPhase 2NCT05035927
Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder
A Phase 2 study testing TRYP-0082 and Psychotherapy in people with Binge Eating Disorder, run by TRYP Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- TRYP-0082 and Psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 7 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To participate in this study, subjects will have to meet all of the following criteria:
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for BED.
- Age ≥18 and ≤64 years.
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 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.
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- 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.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner through 90 days post-dose.
- 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.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages for a minimum of 1 week prior to drug administration.
- 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.
Who cannot join
- To participate in this study, subjects must not meet any of the following criteria:
- 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.
- Participation in another concurrent clinical study or within the preceding month.
- Women who are pregnant or who intend to become pregnant during the study or who are currently nursing.
- 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.
- 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.
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- Presence of a gastrointestinal disease that could interfere with absorption of orally-administered TRP 8802.
- Have epilepsy.
- 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.
- Family history of psychosis.
- Meet DSM-5 criteria for a moderate or severe alcohol or drug use disorder.
- 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.
- Prior adverse effects from psilocybin.
- 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).
- 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).
- 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.
- fMRI subjects: Contraindications to fMRI procedures, per institutional policy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder
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.
Read the 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:
- 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).
- Conditions
- Binge Eating Disorder
- Being tested
- TRYP-0082, Psychotherapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRYP-0082Drug
Also called Psilocybin
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.
PsychotherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Open Label Oral Psilocybin | Experimental | Not described Receives: Drug: TRYP-0082; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12 weeks following dosing
Secondary outcomes (3)
Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population.
Magnitude and duration of TRP 8802-induced dissociative effects in participants with BED using the MEQ30 and MRS
Measured: 12 weeks following dosing
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)
Frequency of binge eating episodes as measured by a modified Eating Questionnaire
Measured: 6 Weeks
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)
Waist Circumference and BMI
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start16 Mar 2022
- Primary completion7 Mar 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRYP Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Miller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035927
- Sponsor's protocol ID
- TRYP-001
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT05035927
- Acronym / sponsor ID
- TRYP-001
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- TRYP TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Oral Psilocybin | Experimental | Drug: TRYP-0082, Behavioral: Psychotherapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for BED.
- Age ≥18 and ≤64 years.
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- 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.
Key exclusion criteria (17 listed)
- 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.
- Participation in another concurrent clinical study or within the preceding month.
- Women who are pregnant or who intend to become pregnant during the study or who are currently nursing.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRYP-0082Also: PsilocybinA 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. | Drug | Open Label Oral Psilocybin |
| PsychotherapyA 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. | Behavioural | Open Label Oral Psilocybin |
Primary outcome
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.
3 secondary outcomes
Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population.
Time frame: 12 weeks following dosing
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Miller, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRYP-0082 and Psychotherapy in people with Binge Eating Disorder, run by TRYP Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.