Phase 2 Depression and Anxiety Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults between the ages of 18 and 65.
- People who are assessed by study staff as having the mental capacity to give informed consent.
- People who can read and communicate in English well enough to understand the consent form and study questionnaires, as assessed by study staff.
- People who are willing to follow all study procedures throughout the trial.
- People whose overall health is assessed by a study doctor as being compatible with the study procedures.
- People who are able to swallow oral medication and are willing to follow the required medication schedule.
- People capable of becoming pregnant who have used highly effective contraception for at least one month before screening and agree to continue doing so throughout the study.
- People who meet the clinical diagnostic criteria (DSM-5) for a current episode of moderate or severe major depressive disorder (without psychotic features) and also have a moderate or severe alcohol use disorder, as confirmed by a structured clinical interview (SCID-5).
- People who score at least 14 on the Hamilton Depression Rating Scale, a standard measure of depression severity.
- People who are not interested in starting standard drug treatments for depression or alcohol use disorder at the time of joining (this will be reviewed again at Week 6 of the study).
- People who are willing to, and safely able to, taper off and stop current antidepressants, antipsychotics, or anti-alcohol/anti-craving medications for at least two weeks before the study baseline visit and for the whole duration of the study, with confirmation from their own doctor that it is safe to do so.
- People who are willing to, and safely able to, taper off and stop certain other specific medications that can interact with the study drug (including certain enzyme inhibitors) for at least two weeks before the baseline visit and for the whole study duration, with confirmation from their own doctor that it is safe to do so (confirm with trial site for the full list of affected medications).
- People who agree to follow the lifestyle guidelines set out in the study protocol for the full duration of the trial.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who are pregnant (confirmed by a urine test at screening and baseline), intend to become pregnant during the study, or are currently breastfeeding.
- People who have a medical reason — whether absolute or relative — that makes taking psilocybin unsafe, including a known drug allergy, recent stroke, uncontrolled high blood pressure (above 160/100 mmHg), low or unstable blood pressure, recent heart attack, heart rhythm problems, severe coronary artery disease, or moderate to severe kidney or liver impairment.
- People with a diagnosis of liver cirrhosis, significantly elevated liver enzyme levels (AST or ALT more than three times the upper limit of normal), or other significant abnormal liver function that a study doctor determines would make taking psilocybin unsafe.
- People who have ever been diagnosed with a schizophrenia-spectrum disorder, obsessive-compulsive disorder, a psychotic disorder (unless caused by a substance or a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or a neurocognitive disorder, as determined through medical history and a structured clinical interview.
- People who have a first-degree relative (such as a parent or sibling) diagnosed with a schizophrenia-spectrum disorder, a psychotic disorder (unless caused by a substance or a medical condition), or bipolar I or II disorder, as determined by a family medical history form and discussion with the participant.
- People who show signs of potentially complicated alcohol withdrawal, including a score above 9 on a standard alcohol withdrawal assessment scale (CIWA-Ar) or a score of 4 or higher on another withdrawal severity prediction scale.
- People who use benzodiazepine medications, except for low-dose use (up to the equivalent of 2mg of lorazepam per day) for sleep or anxiety, provided it is not taken within 12 hours before the psilocybin dose session at Week 2.
- People who have been diagnosed with a substance use disorder (not including alcohol, cannabis, tobacco, or caffeine) within the past six months.
- People with certain heart rhythm abnormalities detected on an ECG, including a prolonged QTc interval (above 0.45 seconds for males or 0.47 seconds for females), a condition called Torsade de Pointes, or a history of long QTc syndrome or related risk factors.
- People currently using aldehyde dehydrogenase (ALDH) inhibitors or UGT modulators (confirm with trial site for specific medications).
- People who have used hallucinogenic substances in the past five years, or who have used hallucinogens ten or more times in total over their lifetime.
- People who are currently assessed as being at risk of suicide, based on a standardised assessment tool (C-SSRS) and confirmed by a study doctor's evaluation.
- People with any other significant physical illness, including chronic infectious diseases or other major ongoing health conditions, that a study investigator considers could interfere with the study results or pose a health risk to the participant.
- People who are currently responding positively to anti-alcohol or anti-craving medications.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Adherence; Montgomery-Asberg Depression Rating Scale (MADRS); Hamilton Depression Rating Scale (HAMD-17); Quick Inventory of Depressive Symptomatology - Self Report (QUIDS-SR); Alcohol Timeline Followback (TLFB); Clinical Institute Withdrawal Assessment (CIWA); Prediction of Alcohol Withdrawal Severity Scale (PAWSS); Penn Alcohol Craving Scale (PACS); Addiction Severity Index (ASI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.