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 21 and 65.
- People who are willing and able to sign a consent form before any study-related activities begin, as approved by an ethics review board.
- People who meet the medical definition (DSM-5) for moderate or severe alcohol use disorder within the past 12 months.
- People who have had at least 28 drinks per week (if male) or 21 drinks per week (if female) in the 28 days before signing the consent form.
- People who have had a permanent surgical procedure to prevent pregnancy (such as vasectomy, tubal ligation, or hysterectomy), or who agree to either remain sexually inactive or use a barrier contraceptive (such as a condom) from the start of the study until it is completed, and who agree not to donate sperm for 90 days after receiving the study drug.
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 currently being treated for alcohol use, or who have received treatment or sought treatment in the 30 days before enrolling.
- People who meet the medical definition (DSM-5) for dependence on any mind-altering substances other than nicotine within the past 12 months.
- People who currently meet the medical definition (DSM-5) for a substance use disorder for any substance other than alcohol or nicotine.
- People who have ever been diagnosed with schizophrenia, bipolar disorder, or any psychotic disorder.
- People who currently have a diagnosis of major depressive disorder with thoughts of suicide.
- People whose urine test comes back positive for narcotics, amphetamines, or sedative or sleep-related drugs.
- People showing significant alcohol withdrawal symptoms, as measured by a recognised clinical assessment tool (confirm with trial site).
- Women who are pregnant, breastfeeding, or unwilling to use a reliable form of contraception.
- People with a history of a significant allergic or adverse reaction to any medication.
- People with a clinically significant abnormal heart tracing (ECG), or a specific heart rhythm measurement (QTcF) above a certain threshold (confirm with trial site).
- People with a history of epilepsy, or any clinically significant heart, breathing (except mild asthma), kidney, liver, digestive, blood, hormonal, skin, metabolic, or psychiatric condition, or any uncontrolled medical illness.
- People whose kidney function, as measured by a specific blood test (creatinine clearance), falls outside the normal range.
- People with a history of head injury involving loss of consciousness, or any history of seizures or convulsions, including those caused by fever, alcohol withdrawal, or drug withdrawal.
- People with a history of stomach or bowel surgery that may affect how the body processes medications.
- People who test positive for hepatitis A, hepatitis B, hepatitis C, or HIV.
- People whose liver enzyme levels (AST, ALT, or GGT) are three or more times the upper limit of normal.
- People who test positive for drugs of abuse on a urine screen at the screening visit or the day before the study drug is given.
- People who have received any drug by injection within the 30 days before the study drug is administered.
- People with a notable abnormality in vital signs, including a history of fainting or near-fainting after standing up quickly.
- People who have donated or lost 550 mL or more of blood (including plasma donation), or received a blood transfusion, within 8 weeks before the study drug is administered.
- Women who are pregnant or breastfeeding.
- People who have taken any other experimental or investigational medication within 6 weeks before the study drug is administered.
- People who are currently enrolled in another clinical study.
- People who have previously taken part in this study.
- People whom the study investigator considers unsuitable to participate, for any reason.
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
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Cue-induced alcohol craving; Stress-induced alcohol craving; Subjective response to alcohol; Pain assessments; Safety and tolerability assessment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.