Trial Review

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Trial registered on ANZCTR


Registration number
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ACTRN12626001354370
Ethics application status
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Approved
Date submitted
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9/10/2026
Date registered
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10/11/2026
Date last updated
Help: Date last updated
10/11/2026
Date data sharing statement initially provided
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10/11/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Psilocybin-Augmented Leadership Trial (PAL-001): Psilocybin-augmented professional development on social attitudes in politically engaged adults
Scientific title
Psilocybin-Augmented Leadership Trial (PAL-001): A randomised pilot study of psilocybin-augmented professional development and group facilitation on social attitudes in politically engaged adults
Additional trial identifiers [1] 318009 0
None
Universal Trial Number (UTN)
Trial acronym
PAL-001
Related trial records

Health condition
Health condition(s) studied:
Low interpersonal functioning 343006 0
Condition category
Condition code
Mental Health 339100 339100 0 0
Other mental health disorders
Mental Health 340156 340156 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
PAL-001 is a randomised pilot trial of a psilocybin-augmented professional development program with group facilitation, designed to improve interpersonal functioning in potically engaged adults. The program runs over 13 weeks and has two components. Structured group facilitation program: three blocks of in-person group facilitation sessions led by specialist facilitators, delivered to two groups of ~8 participants. Each block comprises 2 sessions of approximately 6 hours, for a total of 6 sessions over the 13-week program. Sessions take place at the Clinical Psychedelic Lab, Monash University, Notting Hill and are led by two facilitators with expertise in group facilitation, psychotherapy and intergroup dialogue.
- Block 1 (Week 1, consecutive days): establishing group safety and dialogue norms, emotion regulation skill-building, and introducing perspective-taking and active listening practices.
- Block 2 (Week 6 and 7, spaced weekly): exploring the values and experiences underlying participants’ views, continued emotion regulation skill-building, and perspective-taking and active listening practices, structured intergroup dialogue on contentious topics.
- Block 3 (Week 12 and 13, spaced weekly): continued facilitated dialogue; consolidating insights and shifts across the program; translating insights into the values language of participants’ own communities; and planning personal practices and actions for the return to community

Facilitated psilocybin administration: a single 30 mg dose of psilocybin, taken orally as capsules with water, in a controlled clinical environment at the Monash University Department of Psychiatry treatment rooms, with psychological support from two trained Psychedelic Facilitators. This comprises two preparation sessions, one dosing session of approximately 8 hours, and two integration sessions (the day after dosing and about one week later). Preparation: Two 90-minute preparation session will provide an opportunity for the Psychedelic Facilitators to meet the participant, build rapport and trust, provide psychoeducation to prepare the participant for the Dosing Session and the broader psilocybin administration component, and teach non-avoidance techniques and anxiety management strategies.

Preparation sessions also explore participants’ motivation for participating in the trial, and their personal experience of the group facilitation program. The first preparation session will be held online, two weeks before dosing, with the second session held in-person one week before dosing. Dosing: following a pre-dose check-in and safety assessment, the participant takes the capsule and is encouraged to lie down and focus inwardly. During this time, the participant uses eyeshades and listens to a curated music playlist. Facilitators offer non-directive support as needed. When the acute effects subside, the Facilitators debrief the participant and complete safety checks before discharge. One Facilitator is with the participant at all times during dosing. Refreshments are provided, and a Support Person escorts the participant home.

Integration: Two 90-minute integrations sessions will support participants to reflect on and make sense of the Dosing experience and explore how insights from the experience relate to the participant’s relationships, professional role and the group program. The first integration session will be conducted in-person the day after dosing, with the second conducted online one week later. The timing of the dosing session follows each participant’s allocated program schedule. Safety: heart rate, blood pressure and general symptoms are monitored throughout the dosing session. Rescue medication is available if needed. Treatment fidelity: all dosing sessions are video recorded and excerpts are reviewed by an independent expert. Adherence and protocol deviations are documented.
Intervention code [1] 334880 0
Treatment: Drugs
Intervention code [2] 334881 0
Behaviour
Intervention code [3] 335682 0
Treatment: Other
Description of the comparator or control
Participants are randomised 1:1 to one of two program schedules, each a fixed protocol. The schedules differ only in the sequencing of program components (dosing is either in Week 5 or Week 11). All participants complete the same 13-week program, including one psilocybin session. The primary analysis evaluates within-participant change from baseline to Week 14. A between-schedule comparison at Week 8 examines the contribution of the psilocybin component.
Control group
Active

Outcomes
Primary outcome [1] 346409 0
Change in social attitudes
Timepoint [1] 346409 0
Baseline Week 8 after Baseline Week 14 after Baseline (primary timepoint).
Secondary outcome [1] 465743 0
Safety is measured as a composite outcomes by the incidence of and severity of adverse events (AEs) and serious adverse events (SAEs), and suicidality.
Timepoint [1] 465743 0
AE/SAE: Baseline; each of the two preparation sessions; the dosing session (pre-dose and end of session); each of the two integration sessions; and Weeks 8, 14, 26 and 52 post-baseline. Suicidality: Baseline; each of the two preparation sessions; the dosing session (pre-dose); each of the two integration sessions; and Weeks 8, 14, 26 and 52 post-baseline.
Secondary outcome [2] 468576 0
Acceptability
Timepoint [2] 468576 0
Week 14 after Baseline.
Secondary outcome [3] 470159 0
Cognitive flexibility
Timepoint [3] 470159 0
Baseline and 8, 14, 26 and 52 weeks post baseline.
Secondary outcome [4] 470160 0
Empathy
Timepoint [4] 470160 0
Baseline and 8, 14, 26 and 52 weeks post baseline.
Secondary outcome [5] 470161 0
Wellbeing
Timepoint [5] 470161 0
Baseline and 8, 14, 26 and 52 weeks post baseline.
Secondary outcome [6] 470162 0
Social Distance
Timepoint [6] 470162 0
Baseline and 8, 14, 26 and 52 weeks post baseline.

Eligibility
Key inclusion criteria
* Aged 21 to 75 years.
* Able to swallow capsules.
* Sufficient capacity to provide informed consent.
* Medically stable, as determined by screening (personal interview, medical questionnaire, physical examination, ECG, and routine blood laboratory tests).
* If of childbearing potential: not pregnant or breastfeeding at screening, negative pregnancy test prior to the Dosing Session, and agreement to use adequate contraception from screening through 10 days after the Dosing Session.
* Elevated score on a screening measure of social attitudes.
* Agreement to the full set of trial requirements, including adherence to all intervention and assessment processes; video/audio recording of sessions; provision of an appropriate Support Person able to transport the participant after the Dosing Session; alcohol limits (below Australian guidelines, with abstinence 48 h before and after dosing); and a light, low-fat breakfast on the Dosing Session morning.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Potential participants are ineligible if they meet any of the following:
* Hypersensitivity to any ingredient in the investigational drug formulation.
* Suicide risk above protocol thresholds.
* Lifetime history of schizophrenia or other psychotic disorder, bipolar I or II disorder, dissociative identity disorder, or personality disorder (DSM-5); or a first-degree relative with a psychotic disorder or bipolar I disorder.
* Current or past-year DSM-5 disorder, unless judged compatible with a healthy sample by the Principal Investigator
*Taking a contraindicated medication that cannot be ceased for an appropriate length of time during the trial.
* Weight <48 kg or BMI <17.
*Contraindicated medical conditions including cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insufficiency, diabetes, and hypothyroidism.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A modified Zelen design is employed, whereby randomisation precedes consent. Following an online Pre-Screening Survey establishing key eligibility (including location and a screening characteristic used for stratification), eligible individuals are randomised 1:1 to one of the two conditions. Each participant is then presented with condition-specific study information and consent materials. The allocation sequence is pre-generated and uploaded to REDCap, which allocates participants according to the pre-specified schedule; randomisation is conducted independently of the delivery team via REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted-block randomisation, stratified by a baseline screening characteristic with two categories, so that each condition comprises 8 participants, 4 from each category. The allocation sequence is computer-generated and uploaded to REDCap.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2026
Actual
Date of last participant enrolment
Anticipated
15/06/2027
Actual
Date of last data collection
Anticipated
15/09/2028
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322556 0
University
Name [1] 322556 0
Monash University
Country [1] 322556 0
Australia
Funding source category [2] 322625 0
Charities/Societies/Foundations
Name [2] 322625 0
Morris Family Foundation
Country [2] 322625 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 325477 0
None
Name [1] 325477 0
Address [1] 325477 0
Country [1] 325477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321034 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 321034 0
Ethics committee country [1] 321034 0
Australia
Date submitted for ethics approval [1] 321034 0
30/04/2026
Approval date [1] 321034 0
17/09/2026
Ethics approval number [1] 321034 0

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

Contacts
Principal investigator
Name 152442 0
Dr Paul Liknaitzky
Address 152442 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2, 270 Ferntree Gully Rd, Notting Hill VIC 3168, Australia
Country 152442 0
Australia
Phone 152442 0
+61 3 9905 5004
Fax 152442 0
Email 152442 0
[email protected]
Contact person for public queries
Name 152443 0
Paul Liknaitzky
Address 152443 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2, 270 Ferntree Gully Rd, Notting Hill VIC 3168, Australia
Country 152443 0
Australia
Phone 152443 0
+61 3 9905 5004
Fax 152443 0
Email 152443 0
[email protected]
Contact person for scientific queries
Name 152444 0
Paul Liknaitzky
Address 152444 0
Clinical Psychedelic Lab, Monash University, Level 1, Building 2, 270 Ferntree Gully Rd, Notting Hill VIC 3168, Australia
Country 152444 0
Australia
Phone 152444 0
+61 3 9905 5004
Fax 152444 0
Email 152444 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.