Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPlaceboActive not recruiting

Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial

This randomized, double-blinded, placebo-controlled trial (n=100) tests whether a single 25 mg oral psilocybin capsule reduces heavy drinking days in patients with alcohol use disorder.

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

Detailed Description

Randomised, double-blind, placebo-controlled, single-site Phase II trial in Denmark evaluating a single 25 mg oral dose of psilocybin (PEX010) versus placebo in patients with alcohol use disorder (n=100).

Primary outcome is percentage of heavy drinking days over the last 28 days at 12-week follow-up; secondary outcomes include total alcohol consumption, abstinent days, craving scales, liver biomarkers, pharmacokinetics of psilocin, and fMRI measures.

The trial includes comprehensive safety monitoring, assessment of the acute psychedelic experience with validated questionnaires, and exploration of brain network changes related to treatment response.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral administration of psilocybin (PEX010) as a 25 mg capsule.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    PEX010 psilocybin capsules (25 mg); dry extract from Psilocybe cubensis (15–25:1).

Placebo capsule

inactive

Matching placebo capsule, oral.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Matching placebo capsule (capsule form).

Participants

Ages
20 – 70
Sexes
Male & Female

Inclusion Criteria

  • 1. Age 20–70 years inclusive.
  • 2. Body weight 60–95 kg inclusive.
  • 3. Diagnosed with alcohol use disorder (DSM-5) and alcohol dependence (ICD-10).
  • 4. AUDIT ≥ 15.
  • 5. ≥5 heavy drinking days (men >60 g/day; women >48 g/day) in the past 28 days measured by TLFB.

Exclusion Criteria

  • 1. Personal or first-degree relative with current or previous psychotic spectrum disorder or bipolar disorder.
  • 2. History of delirium tremens or alcohol withdrawal seizures.
  • 3. History of suicide attempt or current suicidal ideation.
  • 4. Withdrawal symptoms at inclusion (CIWA-Ar > 9).
  • 5. Severe neurological disease (including head trauma with LOC >30 min).
  • 6. Impaired hepatic function (ALT/AST >3× ULN).
  • 7. Cardiac problems (decompensated heart failure NYHA III–IV, unstable angina, or MI within 12 months).
  • 8. Abnormal ECG.
  • 9. Impaired renal function (eGFR <50 ml/min).
  • 10. Uncontrolled hypertension (SBP >165 mmHg or DBP >95 mmHg).
  • 11. Current pharmacotherapy for AUD (disulfiram, naltrexone, acamprosate, nalmefene) within 28 days.
  • 12. Treatment with serotonergic medication or use of serotonergic psychedelics within 1 month.
  • 13. Other active substance use disorder (DUDIT >6/2) except nicotine.
  • 14. Women of childbearing potential who are pregnant, breastfeeding, intending pregnancy, or not using highly effective contraception.
  • 15. Hypersensitivity to active substance or excipients.
  • 16. Contraindications to fMRI (for scan subgroups).
  • 17. Unable to speak/understand Danish.
  • 18. Any condition judged by investigator to interfere with participation.

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment100 participants
  • Timeline
    Start: 2020-12-16
    End: 2024-09-30
  • Compounds
    PsilocybinPlacebo
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Denmark

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