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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000316303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/02/2026
Date registered
Help: Date registered
12/03/2026
Date last updated
Help: Date last updated
2/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
PANDA: Psilocybin-assisted therapy for treatment of alcohol use disorder and comorbid depression
Scientific title
PANDA: An Open Label Pilot Study of Single-Dose Psilocybin-Assisted Therapy for the Treatment of Alcohol Use Disorder with Comorbid Major Depressive Disorder in routine Alcohol and Other Drugs practice
Additional trial identifiers [1] 316578 0
EH_20082025
Universal Trial Number (UTN)
Trial acronym
PANDA
Related trial records

Health condition
Health condition(s) studied:
Alcohol Use Disorder 340753 0
Major Depressive Disorder 340754 0
Condition category
Condition code
Mental Health 336935 336935 0 0
Addiction
Mental Health 336970 336970 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Psilocybin-Assisted Therapy for Alcohol Use Disorder and Depression

This study explores psilocybin-assisted therapy for adults with alcohol use disorder and co-occurring depression.

Drug Component

Psilocybin will be administered as part of the intervention in a single oral dose during a supervised session.

Dose: A single oral dose of 25 mg of psilocybin

Administration Mode: Oral capsule

Duration: One dosing session

Setting: Dosing will occur in a controlled clinical environment with medical oversight, in line with regulatory requirements.

Psychological Therapy Component

The psilocybin dosing will be integrated into a comprehensive psychological therapy program, which includes both alcohol and drug counselling and psychedelic therapy components (preparation, dosing, and integration sessions).

Alcohol and Drug Counselling:
Alcohol and drug counselling is a core element of this intervention and involves therapy sessions focused on addressing alcohol use, building coping strategies, and supporting the participant’s mental health. Counsellors are trained professionals with expertise in alcohol and drug treatment.

Intervention Procedures and Activities

The psilocybin-assisted therapy consists of three main sessions: preparation, dosing, and integration, along with a series of alcohol and drug counselling sessions.

Alcohol and Drug Counselling Sessions:

Duration: 4 to 6 individual counselling sessions prior to the dosing session.

Focus: These sessions address alcohol use and provide psychological support. Topics include understanding the relationship between alcohol and depression, managing cravings, and fostering coping mechanisms for mental health challenges.

Preparation Session:

Duration: 1 session, approximately 1 to 1.5 hours.

Focus: This pre-dosing session prepares participants for the psychedelic experience, including building therapeutic rapport, providing psychoeducation about the psilocybin experience, setting intentions for the session, and addressing any safety concerns.

Psilocybin Dosing Session:

Duration: 1 session, typically lasting 4 to 6 hours.

Focus: During the dosing session, participants will receive a single oral dose of psilocybin under medical supervision in a comfortable, controlled clinical environment. Psychological support will be available throughout the session to ensure the participant’s comfort and safety.

Integration Session:

Duration: 1 session, approximately 1 to 1.5 hours.

Focus: Post-dosing, the integration session helps participants reflect on their experiences and process any insights gained, particularly in relation to alcohol use and depressive symptoms. The goal is to incorporate these insights into daily life.

Intervention Delivery and Monitoring

Who Delivers the Intervention:

Alcohol and Drug Counselling: Delivered by trained therapists with professional qualifications and experience in mental health and alcohol and drug treatment.

Psilocybin-assisted Sessions: Facilitated by the alcohol and drug counsellor, alongside a clinician trained in psychedelic-assisted therapy (e.g., clinical psychologist or psychiatrist).

Medical Oversight: Provided by qualified medical practitioners during the dosing session.

Mode of Delivery:

All sessions are face-to-face and conducted individually.

Frequency and Total Duration

Alcohol and Drug Counselling Sessions: 4 to 6 sessions before the dosing session.

Preparation Session: 1 session before the dosing session.

Psilocybin Dosing Session: 1 session, typically lasting 4 to 6 hours.

Integration Session: 1 session after the dosing session.

Total Duration: The intervention spans approximately 4 to 6 weeks, depending on the number of alcohol and drug counselling sessions required.

Adherence Monitoring

Adherence to the intervention will be monitored through:

Regular check-ins with the alcohol and drug counsellor throughout the process to track progress and address any challenges.

Documentation of each session’s attendance and content.

Post-session assessments to evaluate the participant’s experience and integration of insights gained during the dosing session.
Intervention code [1] 333255 0
Treatment: Drugs
Intervention code [2] 333256 0
Behaviour
Description of the comparator or control
This study is an uncontrolled pilot designed to assess the feasibility, acceptability, and preliminary efficacy of psilocybin-assisted therapy (PAT) within routine alcohol and other drug (AOD) services for adults with co-occurring AUD and depression. As such, there is no control or comparator group in this study. The intervention consists of a single dose of 30 mg of psilocybin combined with psychotherapy, without any placebo or active control arm. The primary goal is to gather initial safety, feasibility, and preliminary efficacy data to guide future controlled research.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344517 0
Recruitment feasibility (screened-to-enrolled participant ratio)
Timepoint [1] 344517 0
Assessed throughout the recruitment period.
Primary outcome [2] 344607 0
Recruitment duration feasibility
Timepoint [2] 344607 0
Assessed throughout the recruitment period.
Secondary outcome [1] 458121 0
Acceptability of psilocybin-assisted therapy
Timepoint [1] 458121 0
Six weeks following psilocybin administration.
Secondary outcome [2] 458122 0
Alcohol Consumption, composite secondary outcome
Timepoint [2] 458122 0
Baseline, six weeks, and twelve weeks following psilocybin administration.
Secondary outcome [3] 458123 0
Depression Symptom severity
Timepoint [3] 458123 0
Baseline, six weeks, and twelve weeks following psilocybin administration.
Secondary outcome [4] 458124 0
Anxiety and stress symptoms
Timepoint [4] 458124 0
Baseline and twelve weeks following psilocybin administration.
Secondary outcome [5] 458125 0
Post-traumatic stress disorder symptoms
Timepoint [5] 458125 0
Baseline, six weeks, and twelve weeks following psilocybin administration.
Secondary outcome [6] 458126 0
Motivation for alcohol use
Timepoint [6] 458126 0
Baseline, six weeks, and twelve weeks following psilocybin administration.
Secondary outcome [7] 458127 0
Participant experience and engagement with psilocybin-assisted therapy, this will be assessed as a composite outcome
Timepoint [7] 458127 0
Across the study period, with key assessments at one week and six weeks following psilocybin administration.
Secondary outcome [8] 458128 0
Safety and tolerability of psilocybin-assisted therapy, this will be assessed as a composite outcome
Timepoint [8] 458128 0
One week, six weeks, and twelve weeks following psilocybin administration.
Secondary outcome [9] 458129 0
Inflammation and neuroplasticity biomarkers, this will be assessed as a composite outcome
Timepoint [9] 458129 0
Baseline, one week, and six weeks following psilocybin administration.
Secondary outcome [10] 458130 0
Objective sleep parameters, this will be assessed as a composite outcome
Timepoint [10] 458130 0
Baseline and six weeks following psilocybin administration.

Eligibility
Key inclusion criteria
Adults aged 18 years or older

Meet Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5) criteria for moderate alcohol use disorder within the past 12 months

Have moderate depressive symptoms, defined as a score greater than 14 on the Beck Depression Inventory (second edition)

Seeking treatment for alcohol use disorder

Have adequate cognitive capacity and English language proficiency to provide informed consent and complete study procedures

Have stable housing

Willing and able to attend multiple in-person study visits and participate in psilocybin-assisted therapy and follow-up assessments

Provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Pregnant or breastfeeding

Current use of excluded psychotropic medications, including serotonin–noradrenaline reuptake inhibitors, monoamine oxidase inhibitors, tricyclic antidepressants, mood stabilisers, or antipsychotic medications (unless an approved washout period has occurred at investigator discretion)

Moderate or severe substance use disorder (DSM-5 criteria) other than alcohol, with the exception of cannabis or nicotine

Clinically significant or unstable medical (e.g. serious systemic illness or end-stage liver disease) or psychiatric (e.g. high suicide risk) condition that in the opinion of the investigator, would preclude safe study participation

Personal or family history of psychotic disorder

Recent alcohol pharmacotherapy, defined as use within 30 days prior to treatment initiation

Clinically significant alcohol withdrawal, defined as a Clinical Institute Withdrawal Assessment for Alcohol score of 10 or greater

Current participation in another clinical trial involving an investigational medicinal product

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
12/01/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 45480 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 321196 0
Government body
Name [1] 321196 0
Funding is provided by an Eastern Health Foundation grant
Country [1] 321196 0
Australia
Primary sponsor type
Government body
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 323899 0
None
Name [1] 323899 0
Address [1] 323899 0
Country [1] 323899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319726 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 319726 0
Ethics committee country [1] 319726 0
Australia
Date submitted for ethics approval [1] 319726 0
22/12/2025
Approval date [1] 319726 0
09/02/2026
Ethics approval number [1] 319726 0

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

Contacts
Principal investigator
Name 148194 0
A/Prof Shalini Arunogiri
Address 148194 0
Turning Point, Level 2, 110 Church Street, Richmond, Victoria, 3121
Country 148194 0
Australia
Phone 148194 0
+61417740912
Fax 148194 0
Email 148194 0
[email protected]
Contact person for public queries
Name 148195 0
Liron van Heerden
Address 148195 0
Turning Point, Level 2, 110 Church Street, Richmond, Victoria, 3121
Country 148195 0
Australia
Phone 148195 0
+61 0409 033 819
Fax 148195 0
Email 148195 0
[email protected]
Contact person for scientific queries
Name 148196 0
Sarah Catchlove
Address 148196 0
Turning Point, Level 2, 110 Church Street, Richmond, Victoria, 3121
Country 148196 0
Australia
Phone 148196 0
+61 409033819
Fax 148196 0
Email 148196 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.