Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPlaceboUnknown status

Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Randomised, double-blind, placebo-controlled Phase II trial (n=90) testing a single 25 mg dose of psilocybin plus psychological support versus placebo in treatment-seeking adults (20–70 yrs) with alcohol use disorder.

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

Detailed Description

This single-centre, randomised, double-blinded, placebo-controlled 1:1 parallel-group trial will compare a single 25 mg dose of psilocybin plus psychological support with placebo plus psychological support in 90 patients with alcohol use disorder.

Primary outcome is reduction in percentage of heavy drinking days from baseline to 12 weeks. Key secondary outcomes include phosphatidyl-ethanol as an objective biomarker, plasma psilocin levels, and acute subjective drug experience; fMRI one week post dosing will explore neurobiological mechanisms.

Patients receive psychological support before, during and after dosing with outcome assessments at weeks 1, 4, 8 and 12.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin-assisted therapy

experimental

Single administration of 25 mg psilocybin given with psychological support before, during and after dosing.

Interventions

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

    Given within a protocol of psychological support

Placebo-assisted therapy

inactive

Single administration of placebo (maltodextrin) given with psychological support before, during and after dosing.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Maltodextrin (placebo)

Participants

Ages
20 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Bodyweight of 50-110 kg
  • AUD according to DSM-5 criteria and alcohol dependence according to ICD-10
  • AUD Identification Test (AUDIT) ≥ 15
  • ≥ 5 heavy drinking days in the past 28 days prior to inclusion
  • Citizens of Denmark

Exclusion Criteria

  • Exclusion Criteria:
  • Current or previously diagnosed with any psychotic disorder or bipolar affective disorder
  • Immediate family member with a diagnosed psychotic disorder
  • History of delirium tremens or alcohol withdrawal seizures
  • History of suicide attempt or present suicidal ideation at screening
  • Withdrawal symptoms at screening (>9 on the CIWA-Ar)
  • Present or former severe neurological disease including trauma with loss of consciousness > 30 min
  • Impaired hepatic function (alanine transaminase >210/135 units/l men/women)
  • Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg)
  • Present or former abnormal QTc (>450/470 ms men/women)
  • Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion
  • Treatment with any serotonergic medication or drugs within one month prior inclusion
  • Any other active substance use disorders (except nicotine) defined as a DUDIT score >6/2 (men/women) and investigator's clinical evaluation
  • Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective
  • Unable to speak or understand Danish
  • Any other condition that the clinician estimates can interfere with trial participation

Study Details

Locations

Psychiatric Center Copenhagen, Frederiksberg Hospital — Frederiksberg, Denmark

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