Psilocybin-assisted Therapy for Alcohol Use Disorder

Launched by UNIVERSITY OF SYDNEY · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of psilocybin-assisted therapy to help people reduce their alcohol consumption. Psilocybin is a naturally occurring substance found in certain mushrooms, and researchers want to see if it can effectively support individuals with alcohol use disorder (AUD) in cutting back or stopping their drinking. The trial is in Phase 2, which means it's testing the treatment's effectiveness and safety in a controlled setting, but it hasn't started recruiting participants yet.

To be eligible for this study, participants need to be at least 18 years old, have a moderate to severe alcohol use disorder, and want to reduce or stop drinking. They should have been drinking at least 21 standard drinks per week recently and must have received prior treatment for their alcohol use. Participants will need to have stable housing and be able to bring a family member or friend to support them during the study. It’s important to know that certain mental health conditions, recent substance use, and other health factors may prevent someone from participating. If eligible, participants can expect to engage in therapy sessions where they will receive psilocybin, along with support from trained professionals.

Gender

ALL

Eligibility criteria

• 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.