None listed
Conditions
Brief summary
Psilocin facilitates profound psychological experiences that can interrupt rigid, maladaptive thought patterns commonly underlying chronic and treatment-resistant mental illnesses. This open-label study will evaluate the safety and preliminary effects of a novel intravenous (IV, i.e. into the vein) formulation of the psychedelic psilocin (TRP-8803) in Anorexia Nervosa, Fibromyalgia, Generalized Anxiety Disorder, Irritable Bowel Syndrome, Major Depressive Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder. Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 8 weeks, and followed up until 12 weeks post second dose.
Interventions
This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with 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 profes
This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with 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. 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. 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 1, 2, 3). One week later, participants will attend the first dosing session (week 4) in which the investigational medical product (IMP) will be administered in the first dosing session, followed by two sessions of integration psychotherapy; the first within 48 hours after the dosing session (week 4) and the second a week later (week 5). Participants will attend a second dosing session (week 6) to receive the IMP, followed by three sessions of integration psychotherapy, the first being with 48 hours of the dosing session, then once a week thereafter (weeks 6, 7, 8). All psychotherapy sessions will be scheduled for 90 minutes, however, sessions can be extended if required. Psychotherapy sessions will be primarily conducted face-to-face, however, online sessions (e.g., Microsoft Team or Zoom) can be organised under specific and approved circumstances (i.e., illness, distance). Treatment will be delivered to individual participants separately. Adherence to trial protocol (i.e., session attendance) will be documented. TRP-8803 ADMINISTRATION: On dosing days, TRP-8803 will be administered intravenously. 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 (total dose 10mg/140 minutes). Participants will be required to remain on site until they are cleared for safe discharge by the facilitating therapists, which may take upwards of 4 hours post infusion.
Sponsors
Tryptamine Therapeutics
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Individuals must meet the following criteria to be considered eligible for study participation: • Illness duration > 24 months. • Has previously undertaken recognised first-line treatment(s) appropriate to the participant’s indication under study. • If concurrent treatment, agree to maintain the current treatment regimen during the trial unless a change is clinically required. • Aged 18 to 60 years (inclusive) at the time of completing Stage 1 online screening. • Voluntary consent to participate in the study and to undergo all study procedures. • Ability to receive intravenous (IV) medication (i.e., adequate venous access) and willingness to adhere to the study regimen. • Medically stable, in the judgement of the Medical Officer • Agree to follow the directions of the Medical Officer regarding the consumption of non-prescription and prescription medications and supplements. • Willing and able to follow dosing day instructions provided by the facilitating therapists. • Agree not to operate motor vehicles or heavy machinery for 24 hours following discharge after each dosing session. • Agree to arrange transport assistance by a support person following each dosing session. • Able to provide contact details of their primary care physician or medical practice, and provide consent for trial staff to contact them if necessary. • Non-smokers. • Agree not to use nicotine-containing products for duration of participation. • No use of psychedelic drugs for at least 3 months prior to psilocin administration. • Agree to refrain from psychedelic use (other than study drug) during the study. Psychedelics include, but are not limited to, psilocybin, lysergic acid diethylamide (LSD), methylenedioxymethamphetamine (MDMA), ibogaine, and ayahuasca. Any other suspected psychedelic use must be discussed with and approved by the Sponsor. • Women of childbearing potential (WOCBP) in sexual relationships with men must agree to use two acceptable forms of contraception from 30 days prior to screening until 30 days after the final dose of study drug. • WOCBP must agree to refrain from donating ova (eggs) for at least 30 days after the final dose of study drug. • Men must agree to avoid impregnating women and refrain from sperm donation during treatment and for 90 days after the final dose of study drug, using acceptable contraception methods. • Meet all additional indication-specific inclusion criteria.
Exclusion criteria
The following exclusion criteria apply to all individuals considered for study participation: • Requirement to withhold, interrupt, or taper an effective standard of care solely to enable trial participation. • Unstable standard of care regimen or clinical circumstances that, in the investigators’ judgement, would confound safety assessment or increase risk. • Participant has a recent history of suicide attempt, defined as an active, interrupted, or aborted suicide attempt within the previous 12 months, or presents with current suicidal ideation indicating an unacceptable risk. Participants who report passive suicidal ideation only (e.g., wish to be dead, without plan or intent) may be considered to inclusion if deemed safe by the medical officer or lead psychiatrist. • Current or history of psychosis symptoms or related conditions, including bipolar disorder. • First-degree family history of bipolar disorder, or first- or second-degree family history of schizophrenia or schizoaffective disorder. • History of alcohol use disorder within 12 months prior to screening or regular abuse of alcohol within the previous 12 months. • History of substance use disorder (other than alcohol) within 12 months prior to screening or regular abuse of alcohol within the past 12 months. • History of adverse effects from psilocybin or other psychedelics (e.g., severe headache or severe hypertension requiring medical treatment), based on self-report. • History of Hallucinogen Persisting Perception Disorder (HPPD). • Presence of any serious medical condition that, in the judgement of the medical officer or lead psychiatrist, may interfere with safe participation in the trial (e.g., cardiovascular, metabolic, neurological, respiratory, oncological, haematological disorders, epilepsy, or seizures). • Under treatment for epilepsy. • Cardiovascular conditions including: uncontrolled hypertension, angina, clinically significant ECG abnormalities, transient ischaemic attack (TIA) within the past 6 months, stroke or cerebrovascular disease, peripheral or pulmonary vascular disease (if symptomatic or with active claudication). Exclusion also applies to abnormal ECG parameters identified at screening or from medical history, including QTc greater than 450 ms for men and greater than 470 ms for women, PR interval greater than 220 ms, or QRS duration greater than 120 ms. • Clinically concerning haematological, electrolyte, renal, or liver function test results at screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 x upper limit of normal (ULN), or total bilirubin = 1.5 x ULN. Individuals with certain abnormal values may participate if they received medical clearance from their medically qualified healthcare provider or the medical officer on a case-by-case basis. • Insulin-dependent diabetes mellitus. Participants with non-insulin-dependent diabetes treated with oral hypoglycaemic agents will be excluded if they have a history of hypoglycaemia. • Serious infection requiring hospitalisation within the previous 28 days prior to dosing. • Women of childbearing potential who are pregnant, breastfeeding, or actively trying to conceive. • Participation in another clinical study involving investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to screening. • Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at screening. • Positive test result for illicit substances or drugs of abuse on the day of dosing, prior to session commencement. • Unless pre-approved by the Medical Officer. • Positive alcohol test on the day of dosing, prior to session commencement. • Donation of blood or blood products greater than 500 mL within 30 days prior to screening. • Participants may be excluded at the discretion of the investigators if, in their judgment, participation poses a safety risk, would compromise data integrity, or would interfere with the safe and effective delivery of the intervention. This includes, but is not limited to, the presence of unmanaged psychiatric conditions (e.g., personality disorders, cPTSD), significant adverse childhood experiences (e.g., trauma), or current psychosocial instability (e.g., inadequate social support, unstable housing, or exposure to domestic violence) that would impair therapeutic rapport or the participant’s ability to safely undergo the intervention. This determination will be based on eligibility review and may include consultation with the participant’s healthcare team if appropriate. • Meet additional indication-specific exclusion criteria.
Outcome results
None listed