Psilocybin-assisted Therapy for Alcohol Use Disorder

NCT ID: NCT06444243

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed Description

New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being. This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days (HDD) per week among individuals with AUD.

Primary Objective

To conduct a double-blind, randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder (AUD). The primary aim is to compare the efficacy of psilocybin-assisted therapy (two sessions of psilocybin, 25 mg per dosing session) versus control (niacin 250mg) and therapy in reducing alcohol consumption, specifically measuring the number of heavy drinking days (HDD) per week.

Secondary Objectives

To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD, including depression and anxiety.

Study Design

The trial will employ a double-blind, randomised, controlled design. A sample of 90 individuals with AUD will undergo 14 weeks of treatment, which includes 12 therapy sessions and 2 dosing sessions with either psilocybin (25 mg) or control (niacin 250mg). Participants will be assessed for changes in alcohol consumption patterns and improvements in symptoms of depression and anxiety.

Conditions

Alcohol Use Disorder; Alcohol Dependence; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Psilocybin + Therapy

• 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

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

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

Niacin + Therapy

• 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

Group Type: PLACEBO_COMPARATOR

Niacin

Intervention Type: 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.

Interventions

Psilocybin

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

Intervention Type: DRUG

Niacin

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woke Pharmaceuticals

UNKNOWN

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Haber, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Kirsten C Morley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Central Contacts

Kirsten C Morley, PhD

Role: CONTACT

Kirsten.morley@sydney.edu.au

95153636 ext. 612

Paul Haber, PhD

Role: CONTACT

paul.haber@sydney.edu.au

Other Identifiers

X23-0055

Identifier Type: -

Identifier Source: org_study_id