Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000949482p
Ethics application status
Not yet submitted
Date submitted
28/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the Safety and Effects of the Psychedelic Psilocin on Wellbeing and Anxiety in People with Ongoing Physical and Mental Health Conditions
Scientific title
A Phase 1, Open-label, Single-arm Basket Trial of the Intravenously Administered Psilocin (TRP-8803): Safety, Anxiety, and Quality of Life Across Health Conditions Characterised by Cognitive Inflexibility, Emotional Distress, and Persistent Bodily Symptom Burden
Secondary ID [1] 314998 0
TRYP-007
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study i) is a follow-up to ACTRN12624000547549; and ii) running in parallel to ACTRN12625000330448

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 338323 0
Body Dysmorphic Disorder 338324 0
Chronic Fatigue Syndrome 338325 0
Fibromyalgia 338326 0
Generalized Anxiety Disorder 338327 0
Irritable Bowel Syndrome 338328 0
Long COVID 338329 0
Major Depressive Disorder 338330 0
Obsessive Compulsive Disorder 338331 0
Post Traumatic Stress Disorder 338332 0
Condition category
Condition code
Mental Health 334621 334621 0 0
Anxiety
Mental Health 334622 334622 0 0
Depression
Mental Health 334623 334623 0 0
Eating disorders
Mental Health 334624 334624 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTIONAL: This is a phase 1 open label uncontrolled trial of TRP-8803 (Psilocin) administered intravenously in conjunction with 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. 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 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. 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). 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.
Intervention code [1] 331588 0
Treatment: Drugs
Intervention code [2] 331589 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342312 0
To examine the safety of a two-dose regimen of TRP-8803 administered in combination with psychotherapy.
Timepoint [1] 342312 0
i) During TRP-8803 dosing sessions via continuous therapists monitoring of participant physical and mental wellbeing for emergent AEs commencing prior to IMP administration until discharge. Blood pressure, HR, and ECG will be measured during IMP administration using an automated device and recorded in the source documentation at the following intervals: • Ninety minutes before dosing • Within 15 minutes, 30 minutes, and 45 minutes (± 10 minutes) after the start of the infusion • Within 1 hour (± 20 minutes) after the start of the infusion • Within 1.5 hours (± 20 minutes) after the start of the infusion • Within 2 hours (± 30 minutes) after the start of the infusion and every hour afterwards until the end of the session. ii) Through to 12 weeks following the second dosing session (week 16) via a) scheduled post-dose psychotherapy, c) medical examinations completed c1) within 24 hours of dosing, c2) at first integration psychotherapy session post dose, c3) 4 weeks post dose 2, and c4) 12 weeks post dose 2. d) weekly online wellbeing monitoring checks commencing baseline, weekly, until week 16 e) 4 and 12 week post dose 2 follow up assessments, f) participant initiated contact with trial team.
Secondary outcome [1] 450299 0
To examine the effect of a two-dose regimen of TRP-8803 administered in combination with psychotherapy on researcher-rated anxiety
Timepoint [1] 450299 0
4 and 12 weeks following the second dosing session (weeks 8, 16), compared to baseline.
Secondary outcome [2] 450300 0
To examine the effect of a two-dose regimen of TRP-8803 administered in combination with psychotherapy on self-reported anxiety
Timepoint [2] 450300 0
4 and 12 weeks following the second dosing session (weeks 8, 16), compared to baseline.
Secondary outcome [3] 450301 0
To examine the effect of a two-dose regimen of TRP-8803 administered in combination with psychotherapy on quality of life
Timepoint [3] 450301 0
4 and 12 weeks following the second dosing session (weeks 8, 16), compared to baseline.
Secondary outcome [4] 450302 0
To examine the effect of a two-dose regimen of TRP-8803 administered in combination with psychotherapy on satisfaction with life.
Timepoint [4] 450302 0
4 and 12 weeks following the second dosing session (weeks 8, 16), compared to baseline.
Secondary outcome [5] 450303 0
To examine the effect of a two-dose regimen of TRP-8803 administered in combination with psychotherapy on personal recovery
Timepoint [5] 450303 0
4 and 12 weeks following the second dosing session (weeks 8, 16), compared to baseline.

Eligibility
Key inclusion criteria
The following criteria must be met by all individuals considered for study participation:
• Current diagnosis of one of the following conditions: Anorexia Nervosa, Body Dysmorphic Disorder, Chronic Fatigue, Fibromyalgia, Generalized Anxiety Disorder, Irritable Bowel Syndrome, Long COVID, Major Depressive Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder
• Aged 18 to 65 years (inclusive) at the time of completing Stage 1 online screening.
• Voluntary consent to participate in the study (including follow-up visits) 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 and Lead Psychiatrist, as determined by medical history, physical examination, ECG, and routine laboratory assessments (including haematology, biochemistry, blood, and urinalysis).
• Willing and able to follow dosing day instructions provided by the facilitating therapists, including:
o Consuming approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) as consumed on a usual morning. If not routinely consuming caffeine, participant must refrain from doing so on session days.
o Consuming no more than a light breakfast on the morning of dosing.
• Agree to follow the directions of the Medical Officer regarding the consumption of non-prescription and prescription medications and supplements
• 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.
• Participants currently taking medications contraindicated with the study drug or its effects must undergo a supervised medication taper or cessation prior to baseline, as deemed appropriate and approved by the prescribing physician.
• 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 from 90 days prior to Stage 1 Screening through study termination.
• No use of psychedelic drugs for at least 3 months prior to psilocin administration, and 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participant has a recent history of suicide attempt, defined as an active, interrupted, or aborted suicide attempt within the past 12 months, or presents with current suicidal ideation indicating elevated risk. Participants who report passive 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 past 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.
• Meets diagnostic criteria for borderline personality disorder.
• Testing positive on urine drug screening for drugs of abuse.
• 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).
• Currently 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 >450 ms for men and >470 ms for women, PR interval >220 ms, or QRS duration >120 ms.
• Serious abnormal haematology, electrolyte, renal, or liver function test results at screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal 2 x upper limit of normal (ULN), or total bilirubin greater than or equal to 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 past 28 days.
• 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 saliva test for illicit substances or drugs of abuse on the day of dosing, prior to session commencement.
• Positive alcohol breathalyser reading on the day of dosing, prior to session commencement.
• Donation of blood or blood products >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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
The primary and secondary objectives will be examined at multiple levels, including i) pooled analyses across the entire participant sample, as well as subgroup analyses within each ii) domain and iii) indication.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319550 0
Commercial sector/Industry
Name [1] 319550 0
Tryptamine Therapeutics
Country [1] 319550 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tryptamine Therapeutics
Address
Country
Australia
Secondary sponsor category [1] 322061 0
None
Name [1] 322061 0
Address [1] 322061 0
Country [1] 322061 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318124 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 318124 0
Ethics committee country [1] 318124 0
Australia
Date submitted for ethics approval [1] 318124 0
29/08/2025
Approval date [1] 318124 0
Ethics approval number [1] 318124 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143194 0
Prof Susan Rossell
Address 143194 0
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 143194 0
Australia
Phone 143194 0
+61 3 9214 8173
Fax 143194 0
Email 143194 0
[email protected]
Contact person for public queries
Name 143195 0
Dr Sean Carruthers
Address 143195 0
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 143195 0
Australia
Phone 143195 0
+61 3 9214 3354
Fax 143195 0
Email 143195 0
[email protected]
Contact person for scientific queries
Name 143196 0
Dr Sean Carruthers
Address 143196 0
Centre for Mental Health and Brain Sciences, Swinburne University of Technology, John Street, Hawthorn, VIC, 3122
Country 143196 0
Australia
Phone 143196 0
+61 3 9214 3354
Fax 143196 0
Email 143196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
Following a 36-month embargo period after publication of the primary trial findings

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Figshare

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Statistical analysis plan  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.