Psilocybin-assisted Therapy for Alcohol Use Disorder

NCT06444243 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: X23-0055
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alcohol Use Disorder; Alcohol Dependence; Depression; Anxiety

Keywords

Psilocybin-assisted therapy; Randomised-Controlled Trial; Psilocybin; Psychedelic-Assisted Therapy; Alcohol Use Disorder Therapy

Outcome Measures

Primary Outcomes (1)

• Frequency of Heavy Drinking Days (HDD)

  Frequency of HDD as measured by the Timeline Follow Back (TLFB) and validated by Phosphatidylethanol (PEth). HDD are defined as ≥4 drinks/day for women and ≥5 drinks/day for men.

  52 Weeks

Secondary Outcomes (11)

• Mean alcohol consumption per drinking day

  52 Weeks

• Absence of any HDD

  52 Weeks

• WHO drinking risk level

  52 Weeks

• Dependence Severity

  52 Weeks

• Alcohol Craving

  52 Weeks

Study Arms (2)

Psilocybin + Therapy

EXPERIMENTAL

* 12 weekly sessions of psychotherapy for AUD * 2 dosing sessions - psilocybin 25mg * Additional open-label dosing session for participants in control arm post-follow up * 2 integration sessions following each dosing session (additional dosing session for open label dosing) * 3 post-treatment follow-up sessions * Total of 13 clinic sessions

Drug: Psilocybin

Niacin + Therapy

PLACEBO COMPARATOR

* 12 weekly sessions of psychotherapy for AUD * 2 dosing sessions - niacin 250mg * 2 integration sessions following each dosing session * 3 post-treatment follow-up sessions * Total of 13 clinic sessions

Drug: Niacin

Interventions

Psilocybin DRUG

Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi.

Psilocybin + Therapy

Niacin DRUG

A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Niacin helps some enzymes work properly and helps skin, nerves, and the digestive tract stay healthy. Niacin is found in many plant and animal products. Niacin will be used at a concentration of 250mg as an active control.

Niacin + Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe AUD according to the DSM-5 criteria
• A desire to reduce or stop drinking
• 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
• Aged ≥18 years old
• Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)
• Received prior treatment for AUD (not including study interventions)
• Stable housing within reasonable distance to a clinical site for the duration of the study
• 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
• Willing to give written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• Woke Pharmaceuticals: collaborator

MeSH Terms

Conditions

Alcoholism; Depression; Anxiety Disorders

Interventions

Psilocybin; Niacin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Paul Haber, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Kirsten C Morley, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten C Morley, PhD

CONTACT

95153636; Kirsten.morley@sydney.edu.au

Paul Haber, PhD

CONTACT

paul.haber@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded with an additional optional dosing session for open label dosing
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, Double-blinded, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share