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Alcohol Use DisorderPhase 2NCT06444243

Psilocybin-assisted Therapy for Alcohol Use Disorder

A Phase 2 study testing Psilocybin and Niacin in people with Alcohol Use Disorder and Alcohol Dependence, run by University of Sydney.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Psilocybin and Niacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
No sites listed yet
Study dates
Sep 2024to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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.
  • 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).
  • 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).
  • 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.
  • 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.

Trial locations and contacts

No sites are listed yet.

Kirsten C Morley, PhD contact

95153636 ext. 612

Kirsten.morley@sydney.edu.au

Paul Haber, PhD contact

paul.haber@sydney.edu.au

About this study

Official title: A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder

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

Read the 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.

Being tested
Psilocybin, Niacin
Keywords
Psilocybin-assisted therapy, Randomised-Controlled Trial, Psilocybin, Psychedelic-Assisted Therapy, Alcohol Use Disorder Therapy
Medical subject headings
Alcoholism, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

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

  • NiacinDrug

    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.

Study groups in NCT06444243
Study groupRoleWhat they receive
Psilocybin + TherapyExperimental* 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
Receives: Drug: Psilocybin
Niacin + TherapyPlacebo 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
Receives: Drug: Niacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 52 Weeks

Secondary outcomes (11)

  1. Mean alcohol consumption per drinking day

    The mean alcohol consumption per drinking day will be gathered reported as the number of standard drinks consumed each day.

    Measured: 52 Weeks

  2. Absence of any HDD

    Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels

    Measured: 52 Weeks

  3. WHO drinking risk level

    The WHO categorizes alcohol consumption into different risk levels based on average daily intake and associated health risks: Abstainer: Rarely or never drinks alcohol. Low-risk drinking: (Men: Up to 2 standard drinks per day, Women: Up to 1 standard drink per day). Moderate-risk drinking: (Men: 3-4 standard drinks per day, Women: 2-3 standard drinks per day). High-risk drinking: (Men: More than 4 standard drinks per day, Women: More than 3 standard drinks per day). Heavy episodic (binge) drinking: 60 grams (5-6 drinks) or more on a single occasion.

    Measured: 52 Weeks

  4. Dependence Severity

    Alcohol Dependence Scale (ADS) is a measure of the severity of the participant's dependence on alcohol. The measure contains 29 items regarding symptoms and occurrences associated with dependence on alcohol. A total score for the measure is yielded by adding across items. Higher scores indicate more severe dependence.

    Measured: 52 Weeks

  5. Alcohol Craving

    Alcohol craving will be investigated using the Penn Alcohol Craving Scale (PACS). The PACs is a 5-item questionnaire that measures an individual's craving to drink alcohol in the past week.

    Measured: 52 Weeks

  6. PEth Levels

    PEth measures the level of phosphatidylethanol, a direct alcohol biomarker which is found in human blood following alcohol consumption. Phosphatidylethanols are abnormal phospholipids formed in the presence of ethanol

    Measured: 52 Weeks

  7. Changes in Anxiety

    Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety.

    Measured: 52 Weeks

  8. Changes in Depression

    Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression.

    Measured: 52 Weeks

  9. Changes in Suicidal Ideation

    Changes in suicidal ideation \& behaviours across the treatment period. This will be measured on the C-SRSS (Columbia Suicide Severity Rating Scale). At baseline this will be measured by the baseline version. At each visit following this, this will be recorded on the since last visit version. Higher scores indicate more severe suicidality.

    Measured: 52 Weeks

  10. Changes in Quality of Life

    To assess whether treatment can change quality of life as measured by the short form Health Survey (SF-36). This survey has 36 items that measure 8 domains of health, including: physical functioning, physical role limitations, bodily pain, general health perceptions, energy/vitality, social functioning, emotional role limitations and mental health. The scores are transformed to range from 0 (worst possible health) to 100 (best possible health).

    Measured: 52 Weeks

  11. Markers of Liver Injury

    An assortment of liver enzymes will be monitored throughout the trial to investigate any changes that occur in liver function.

    Measured: 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-centre, Double-blinded, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444243
Sponsor's protocol ID
X23-0055
Status last verified
Jun 2024
First submitted
30 May 2024
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) might not be shared due to privacy concerns, potential misuse of data, intellectual property rights, and ethical considerations. Additionally, legal restrictions and the need to protect sensitive information can also limit the sharing of IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin and Niacin in people with Alcohol Use Disorder and Alcohol Dependence, run by University of Sydney.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirsten C Morley, PhD (95153636 ext. 612, Kirsten.morley@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Heavy Drinking Days (HDD) (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.

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Psilocybin-assisted Therapy for Alcohol Use Disorder | AzTrials