Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPlaceboTerminated

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

Double-blind, placebo-controlled Phase II trial (n=160) evaluating 25 mg psilocybin plus psychotherapy versus placebo in adults with Alcohol Use Disorder (AUD) over 24 weeks.

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

Detailed Description

Multicentre, randomised, double-blind, parallel-group Phase II study comparing a single 25 mg oral psilocybin capsule plus psychotherapy to matching placebo in adults with moderate to severe AUD; primary outcome is monthly number of heavy drinking days over the 8-week treatment period.

Secondary endpoints include total alcohol consumption, proportion with no heavy drinking days, WHO risk level reductions, DSM-5 score change, safety outcomes (AEs/SAEs, labs, vitals, ECG) and measures of the psychedelic experience (5D-ASC, MEQ). The trial was authorised by Finland (Fimea) but was prematurely ended on 2024-12-10.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral 25 mg psilocybin capsule combined with psychotherapy.

Interventions

  • Psilocybin25 mg
    via Oral• single dose

    25 mg psilocybin capsule administered with psychotherapy session.

Placebo capsule

inactive

Matching oral placebo capsule with psychotherapy.

Interventions

  • Placebo
    via Oral• single dose

    Matching placebo capsule.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Moderate to severe Alcohol Use Disorder (AUD) per DSM-5 using structured clinical interview.
  • ≥6 heavy drinking days (HDDs) in a 4-week period prior to V1 OR average alcohol consumption >40 g/day (males) or >20 g/day (females) for 4 weeks prior to V1; and ≥6 HDDs in 4 weeks prior to V5.
  • Expressed desire to reduce or stop alcohol consumption.
  • Able to provide alcohol consumption information for the 4-week period prior to V1.
  • Willingness to participate in behavioural and medicinal treatments for AUD.
  • Subjects of childbearing potential must use highly effective contraception for the trial duration (or meet defined sterilisation/post-menopausal criteria).
  • Generally healthy with no unstable medical conditions as determined by history, exam, labs, ECG, urine analysis and toxicology.

Exclusion Criteria

  • Withdrawal symptoms requiring additional medication (CIWA-Ar score >8).
  • Diagnosis or family history of schizophrenia or prodromal symptoms, any bipolar disorder, OCD, or other psychotic disorder; recent (within 12 months) major depressive episode (HAM-D >19), TRD, PTSD, panic disorder or eating disorders (exceptions noted for some anxiety disorders).
  • Current or recent (within 6 weeks prior to V1) treatment with antipsychotic or antidepressant medications that influence serotonin receptors/transporters.
  • History of hallucinogen use disorder, any use in past year, or >25 lifetime uses.
  • Currently participating or recently (within 4 weeks) participated in an AUD treatment programme.
  • Clinically significant untreated or unstable illness including hepatic dysfunction (AST or ALT >3x ULN or total bilirubin >2x ULN), eGFR <50 mL/min/1.73 m2, significant cardiovascular disease, uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg), or ECG abnormalities (e.g., QTcF >450 ms males, >470 ms females; significant ectopy or conduction block).
  • Allergy or hypersensitivity to psilocybin, other hallucinogens, rescue medications or excipients.

Study Details

Locations

FinlandCanadaBulgaria

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