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Unknown statusPhase 2

Psilocybin-assisted Therapy for Alcohol Use Disorder

NCT06444243 · University of Sydney

Closed to entry
Status
Not accepting participants
Phase 2
Phase
90
Target enrolment
Study sites

What it is testing

Summary

To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Frequency of Heavy Drinking Days (HDD)

    Measured over 52 Weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Moderate to severe AUD according to the DSM-5 criteria 2. A desire to reduce or stop drinking 3. Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks/day for men; ≥4 for women) in the past week prior to screening 4. Aged ≥18 years old 5. Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26) 6. Received prior treatment for AUD (not including study interventions) 7. Stable housing within reasonable distance to a clinical site for the duration of the study 8. Able to identify a significant other (such as a family/friend/partner) who could accompany them from clinic/provide transport and/or be contacted by the study team if required 9. Willing to give written informed consent Exclusion Criteria: * a. History of or currently meeting DSM-5 criteria for: * Any psychotic disorder * Bipolar disorder type 1 or 2 * Major depression with psychotic features * Any personality disorders * Post-traumatic stress disorder * Hallucinogen persisting perception disorder b. A family history of: * Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or * Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV. d. Abnormal and/or serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort/tryptophan), lithium, anticonvulsants). * Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion). * Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures). h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and/or defined by DSM-5 criteria (measured by SCID-RV). i. Substantial lifetime use (\>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month. k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06444243 on ClinicalTrials.gov →

Last updated in the registry 2024-06-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits