Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPlaceboNot yet recruiting

Psilocybin-assisted Therapy for Alcohol Use Disorder

This double-blind, randomised, Phase II trial (n=90) will evaluate the efficacy of psilocybin-assisted therapy (25 mg x2) versus niacin (250 mg x2) plus therapy to reduce heavy drinking days in people with Alcohol Use Disorder.

Target Enrollment
90 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel-group Phase II trial comparing two 25 mg psilocybin dosing sessions plus psychotherapy versus niacin 250 mg plus psychotherapy in adults with moderate to severe AUD; primary outcome is change in heavy drinking days.

Participants receive 12 weekly therapy sessions, two dosing sessions with integration after each dosing (total of four integration sessions), and follow-up visits; secondary outcomes include depression and anxiety symptom change and tolerability.

Study Protocol

Preparation

12 sessions

Dosing

2 sessions

Integration

4 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin + Therapy

experimental

Two psilocybin dosing sessions (25 mg) combined with 12 psychotherapy sessions and integration.

Interventions

  • Psilocybin25 mg
    via Oral• two sessions• 2 doses total

Niacin + Therapy

inactive

Active control (niacin 250 mg) with identical therapy schedule and dosing sessions; optional open-label psilocybin after follow-up.

Interventions

  • Placebo250 mg
    via Oral• two sessions• 2 doses total

    Niacin 250 mg used as active control; open-label psilocybin offered to control arm post-follow-up

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Moderate to severe AUD according to DSM-5 criteria
  • 2. A desire to reduce or stop drinking
  • 3. Consumed at least 21 standard drinks per week or ≥2 heavy drinking days (≥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 (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

  • 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, PTSD, or hallucinogen persisting perception disorder
  • b. 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 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 (antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents such as St John's Wort/tryptophan, lithium, anticonvulsants). Use of antidepressants and alcohol pharmacotherapy considered if titrated down with 5 half-lives + 1-week washout as judged by investigator
  • 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 but 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 other than tobacco as per clinician judgement and/or DSM-5 criteria
  • i. Substantial lifetime use (>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens (psilocybin-containing mushrooms, 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 required and sensitive pregnancy test 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, lack of social support)

Study Details

Locations

Australia

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