A Phase 1, Open-label, Pilot Study to Assess the... — Clinical Trial Details

Binge eating disorder (BED) is the most common eating disorder and is associated with obesity and psychiatric comorbidities. Psilocin taken in combination with talk therapy might be a useful treatment for BED by reducing overall anxiety, anxiety around food, perseveration, and repetitive and intrusive thinking, as well as improving mindfulness and self-compassion. This open-label study will evaluate the safety and efficacy of a novel intravenous (IV, i.e. into the vein) formulation of the psychedelic psilocin (TRP-8803) in 12 people with BED. IV administration of TRP-8803 permits a more rapid start to the psychedelic state compared to psilocin taken orally as a tablet, and allows the administering therapist to control and optimise the dose and if required, rapidly reduce the depth of the psychedelic experience by stopping the infusion (i.e., in case of an adverse effect). Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 6 weeks, and followed up until 12 weeks post second dose. Safety will be assessed. Other indicators of clinical severity will also be explored from baseline through to 12 weeks post second dose.

BED treatment naïve (i.e., have not attempted a form of standardised psychotherapy or pharmacological intervention to treat BED symptoms).
At the time of screening, experiencing moderate to severe levels of depression.
Recent (i.e., 5 year) history of serious suicide attempts requiring hospitalisation or current high suicide risk (i.e., high intent, poor coping, limited protective features, new symptom, intervention required).
History of psychosis: past or present diagnosis DSM-5 of bipolar disorder, schizophrenia, or schizoaffective disorder.
Family history of psychosis: past or present DSM-5 diagnosis of bipolar disorder type 1 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 (including personality disorders), ongoing experience or history of trauma, or other personal or situational factors (e.g., lacking social support, lacking a stable living situation, domestic violence) judged by the investigating team as part of the eligibility review process to be incompatible with establishment of rapport or the safe exposure to treatment.
Meets the DSM-5 criteria for alcohol or drug dependence (excluding caffeine, nicotine) within 12 months prior to screening or regular abuse of alcohol or drugs within 3 months prior to screening.
Currently taking (or where applicable, testing positive on urine drug test), drugs of abuse such as amphetamines, buprenorphine, benzodiazepines, cocaine, methamphetamines, MDMA/Ecstasy, morphine, methadone, oxycodone, marijuana, ethyl glucuronide, fentanyl, tramadol, and synthetic cannabinoids (K2).
Participants will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
Macro-dose (i.e., dose large enough to have perceivable hallucinogenic/psychedelic effects) of any hallucinogen or psychedelic (including psilocybin, LSD, mescaline, DMT, and other similar hallucinogenic compounds) compounds within the past 3 months or high frequency (i.e., over 10 experiences) use across the past 5 years.
Micro-dose of any hallucinogen or psychedelic compounds within the past 3 months.
Prior adverse effects from psychedelics based on self-report.
History of HPPD.
Serious medical condition that, in the judgment of the investigators and medical monitor, will interfere with the ability so safety participate in the treatment e.g., Cardiovascular, Metabolic, Neurological, Respiratory, Oncological, haematological disorder, epilepsy or seizures.
Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication). This could include patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440 ms for men and above 470 ms for women).
Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome
Serious abnormal haematology or electrolyte, renal or liver test result (indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2 or total bilirubin =1.5 x upper limit of normal (ULN), which remains above these limits if provided by their GP or assessed during the screening phase, unless there is specific medical clearance.
Insulin-dependent diabetes; if taking oral hypoglycaemic agents only excluded if they also have a history of hypoglycaemia.
Currently taking (within 5 half-lives dosing days) prohibited medications, including antihypertensive medications, UDP Glucuronosyltransferase Family 1 Member A9 (UGT1A9) or intestinal UDP-glucuronosyltransferases 1A10 inhibitors (eg, regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (eg, disulfiram).
Currently (for at least 2 weeks; or at least 4 weeks for fluoxetine) taking an antidepressant.
Serious infection requiring hospitalisation within the last 28 days.
Women of childbearing potential who are pregnant, nursing, or trying to become pregnant.
Participation in another clinical study involving investigational study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.
Contraindicators to MRI.
Any laboratory test results deemed clinically significant by the medical monitor or Principal Investigator or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
Not suitable for study participation due to other reasons at the discretion of the study investigators
Return a positive saliva drug test on the day of dosing, prior to session commencement
Blood alcohol reading above zero on the day of dosing, prior to session commencement.

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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)

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