Clinical TrialEating DisordersPsilocybinNot yet recruiting

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) two weeks apart, paired with psychedelic-assisted psychotherapy for adults with binge eating disorder (BED).

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label, non-randomised Phase I study of TRP-8803 (psilocin) administered IV in two sessions two weeks apart with cohort-based staggered dosing (options spanning ~6.7–15 mg total per session) and DSMB safety review between cohorts.

All participants receive a therapist dyad delivering preparatory (3×90 min), dosing support, and integration psychotherapy (multiple 90 min sessions); safety assessed via AEs, vitals, ECG, labs and psychiatric measures.

Study Protocol

Preparation

3 sessions
90 min each

Dosing

2 sessions
260 min each

Integration

5 sessions
90 min each

Therapeutic Protocol

supportmindfulness

Study Arms & Interventions

TRP-8803 IV + psychotherapy

experimental

Open-label single-arm administration of intravenous TRP-8803 (psilocin) with preparatory and integration psychotherapy; two dosing sessions two weeks apart; cohort-based staggered dosing with multiple infusion regimens (6.7–15 mg).

Interventions

  • Psilocybin6.7 - 15 mg
    via IV• two sessions• 2 doses total

    Infusion regimens include Option A (LD 5 mg/20 min + MD 6.7 mg/40 min; ~60 min), Option B (LD 5 mg/20 min + MD 10 mg/240 min; ~260 min), Option C (LD 8 mg/30 min + MD 7 mg/120 min; ~150 min). Cohort escalation and DSMB review between cohorts.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • The following criteria must be met by all individuals considered for study participation:
  • 18 to 65 years (inclusive) at time of consent.
  • Diagnosis of BED (minimum 2 years at time of screening) confirmed via SCID-5 (DSM-5 TR) psychiatric interview.
  • Reports 4 or more binge eating episodes per week for the 4 weeks preceding the Stage 1 Online Screening Survey.
  • BMI of 25 or more.
  • Voluntary consent to participate in the study (including follow-up visits) and to undergo the procedures described.
  • Ability to take medication intravenously (adequate venous access) and willingness to adhere to the study regimen.
  • Medically stable in the judgement of the Medical Officer and Principal Investigator, as determined by screening medical, physical examination, ECG, and routine laboratory tests including blood and urinalysis.
  • Agree to consume approximately the same amount of caffeine-containing beverage as usual on dosing mornings (or abstain if not routine).
  • Agree to follow the directions of the Medical Officer regarding the consumption of non-prescription and prescription medications and supplements.
  • Agree that a support person will assist with transport after each dosing session.
  • If required, successful withdrawal of nominated medications prior to baseline.
  • Provide contact details of a treating medical practitioner and consent to contact by trial staff.
  • Non- or ex-smokers and not use nicotine-containing products from 90 days prior to Stage 1 Screening until study termination.

Exclusion Criteria

  • BED treatment naïve (no prior standardised psychotherapy or pharmacological intervention for BED).
  • At screening, experiencing moderate to severe depression.
  • Recent (within 5 years) serious suicide attempts requiring hospitalisation or current high suicide risk.
  • History of psychosis: past or present diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • Family history of psychosis: bipolar I in first-degree relative, or schizophrenia or schizoaffective disorder in first- or second-degree relative.
  • Meets DSM-5 criteria for Anorexia Nervosa or Bulimia Nervosa.
  • Meets DSM-5 criteria for any psychiatric conditions, ongoing trauma, or other factors judged incompatible with safe treatment.
  • DSM-5 alcohol or drug dependence within 12 months or regular abuse within 3 months prior to screening.
  • Currently taking or testing positive for drugs of abuse (amphetamines, buprenorphine, benzodiazepines, cocaine, methamphetamines, MDMA, opioids, cannabis, etc.).
  • Medical requirement to receive certain drugs with low therapeutic index within 12 hours after receiving psilocybin (eg, ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl) — excluded.
  • Macro- or micro-dose use of hallucinogens within the past 3 months or high-frequency use (>10 experiences in 5 years) as specified.
  • Prior adverse effects from psychedelics based on self-report.
  • History of HPPD.
  • Serious medical conditions likely to interfere with safety (cardiovascular, metabolic, neurological, respiratory, oncological, haematological, epilepsy/seizures).
  • Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), angina, clinically significant ECG abnormality, TIA/stroke in last 6 months, peripheral/pulmonary vascular disease.
  • Known conditions risking hypercalcaemia, Cushing's syndrome, hypoglycaemia, SIADH, or carcinoid syndrome.
  • Serious abnormal haematology or electrolyte, renal or liver test results (eg, AST/ALT ≥2x ULN or total bilirubin ≥1.5x ULN) without medical clearance.
  • Insulin-dependent diabetes; oral hypoglycaemics only allowed if no history of hypoglycaemia.
  • Currently taking prohibited medications (eg, certain antihypertensives, UGT1A9/1A10 inhibitors, aldehyde/alcohol dehydrogenase inhibitors) within 5 half-lives.
  • Currently taking antidepressant (within 2 weeks; 4 weeks for fluoxetine) where applicable.
  • Serious infection requiring hospitalisation within last 28 days.
  • Women of childbearing potential who are pregnant, nursing, or trying to become pregnant.
  • Participation in another investigational study within 30 days or 5 half-lives.
  • Contraindications to MRI.
  • Clinically significant lab abnormalities or positive serology for HBsAg, HCV antibody, or HIV antibody at Screening.
  • Not suitable for participation for other reasons at investigators' discretion.
  • Positive saliva drug test or blood alcohol >0 on dosing day prior to session commencement.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2025-06-01
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Unknown facility — Australia

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