None listed
Conditions
Brief summary
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.
Interventions
INTERVENTIONAL: This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with psychedelic-assisted psychotherapy.
PSYCHEDELIC-ASSISTED PSYCHOTHERAPY:
The study is a combined pharmacological and psychological treatment, and as such, each individual participant will receive psychotherapy before, during, and after each dosing session. All participants will be seen by the same two therapists from baseline through to the completion of the stud
INTERVENTIONAL: This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with psychedelic-assisted psychotherapy. PSYCHEDELIC-ASSISTED PSYCHOTHERAPY: The study is a combined pharmacological and psychological treatment, and as such, each individual participant will receive psychotherapy before, during, and after each dosing session. All participants will be seen by the same two therapists from baseline through to the completion of the study. The trial therapists are qualified and experienced mental health professionals (i.e., psychiatrists, psychologists) with specialty training in empirically based therapeutic modalities and psychedelic-assisted psychotherapy. The therapist dyad will typically consist of one male and one female therapist. In every dyad, at least one therapist will be a medically qualified healthcare practitioner. This ensures appropriately qualified staff are able to administer trial medication, both the study drug and any medical interventions if required (i.e., anti-anxiety medication due to persistent psychological distress), and manage any medical events that emerge. The psychotherapy focuses on three distinct phases of this approach: (1) Preparation: emphasising therapeutic alliance, non-avoidance training, psychological and practical preparation for dosing sessions, nature of and relationship to distress, anxiety management strategies, the importance of set and setting, and intention formation; (2) Dosing session: establishing suitable set and setting, and providing non-directive support when necessary; (3) Integration: focus on sustaining the change, emotion and body-focused therapy, meaning-centred integration into wider context, mindfulness training, ongoing peer- and professional support, and facilitating contextual changes to support outcomes. Therapy guides will ensure trial fidelity. The intervention scheduled for all participants will commence with three preparatory psychotherapy sessions over a three-week period (weeks 0, 1, 2), within 48 hours of the third preparatory psychotherapy session the investigational medical product (IMP) will be administered in the first dosing session (week 2), followed by two sessions of integration psychotherapy; the first within 48 hours after the dosing session (week 2) and the second a week later (week 3). Participants will attend a second dosing session (week 4) to receive the IMP, followed by three sessions of integration psychotherapy, the first being with 48 hours of the dosing session the once a week thereafter (weeks 4, 5, 6). All psychotherapy sessions will be scheduled for 90 minutes, however, sessions can be extended if required. Treatment will be delivered to individual participants separately. Adherence to trial protocol (i.e., session attendance) will be documented. TRP-8803 ADMINISTRATION: For Cohort 1, the initial 5 mg loading dose infused over the first 20 minutes will provide a therapeutic dose of psilocin that will be maintained by infusing the maintenance dose of 5 mg over the following 120 minutes. Treatment of Cohort 1 is staggered with at least a 48-hour interval scheduled between the start of psilocin administration for the first and remaining participants, with no more than one participant being dosed on a single day. The nature and severity of any adverse events related to the dosing of the first participant of Cohort 1 will be reviewed by the investigators and the Data Safety Monitoring Board (DSMB) to determine whether to proceed with the remaining dosing for Cohort 1, modify the study, pause the study, or stop the study in accordance with pre-defined discontinuation rules.. After all participants in Cohort 1 have completed the second dose, the investigators and DSMB will review the safety data and prepare a report and recommendation for the Sponsor. Upon reviewing the report and recommendation, the Sponsor will advise as to which administration option Cohort 2 will receive. Cohort 2 will follow the same procedure outlined above for Cohort 1. Any safety data that appears between the last participant of Cohort 1 and first participant of Cohort 2 (i.e., identified during follow-up) will be reviewed by the investigators and DSMB, if required, adjustment to Cohort 2 will be made. All decision making by the investigators, DSMB, and Sponsor will be documented. Option A: LD 5 mg / 20 minutes + MD 6.7 mg / 40 minutes. Total: 6.7 mg / 60 minutes Option B: LD 5 mg / 20 minutes + MD 10 mg / 240 minutes. Total: 15 mg / 260 minutes Option C: LD 8 mg / 30 minutes + MD 7 mg / 120 minutes. Total: 15 mg / 150 minutes
Sponsors
Tryptamine Theraputics
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
The following criteria must be met by all individuals considered for study participation:• 18 to 65-year-old (inclusive; at time of signing consent form at the Stage 2 Screening Interview). • 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 (i.e., has adequate venous access for IV administration) and be willing 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 (e.g., coffee, tea) that they consumes on a usual morning, before arriving at the research unit on the mornings of drug session day. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on a session day. • 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 them personally with transport after each dosing session. • If required, successful withdraw of nominated medications prior to baseline. • Able to provide the contact detail of a medically qualified doctor or medical practice that they are a patient of and give consent for them to be contacted by a trial staff member. • Non- or ex-smokers and not use other nicotine-containing products from 90 days prior to Stage 1 Screening until participant study termination.
Exclusion criteria
• 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.
Outcome results
None listed