Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPlaceboCompleted

Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

Randomised, double-blind, placebo-controlled Phase II parallel trial (n=60) testing a single oral 25 mg dose of psilocybin versus placebo in patients with alcohol use disorder who completed withdrawal within 6 weeks.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, double-blind, placebo-controlled, single-centre Phase II study comparing single-dose oral psilocybin (25 mg) to placebo in patients with alcohol use disorder who have completed withdrawal treatment in the prior six weeks.

Primary outcomes assess effects on alcohol use behaviour and clinical symptoms; mechanistic outcomes include neurocognitive and emotional measures. The protocol includes six clinic visits over six weeks and follow-up surveys at 3 and 6 months.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral dose psilocybin 25 mg administered in clinic; parallel-group active arm.

Interventions

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

    Single oral capsule (25 mg).

Placebo

inactive

Single oral placebo capsule (mannitol).

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo (mannitol 100%).

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Informed Consent as documented by signature
  • Right-handedness according to Oldfield (1971) performed during the telephone screening, laterality index ≥ 0.2
  • DSM-IV-diagnosis of alcohol use disorder (based on clinical assessment and confirmed by the SCID Interview)
  • Having undergone withdrawal treatment from alcohol use or have stopped consuming alcohol within 6 weeks prior to enrolment in the study
  • Drug free from any psychotropic and serotonergic medication for at least five days before administration of the study drug or placebo
  • No alcohol use between withdrawal treatment and administration of study drug or placebo
  • Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology
  • Normal level of language comprehension (German or Swiss-German)
  • Willing to refrain from drinking caffeinated drinks during the testing days and from consuming psychoactive substances after enrolling in the study and for the remainder of the study
  • Women of childbearing potential must be using an effective, established method of contraception for the entire study duration
  • Have a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions (driving is forbidden at drug treatment days)
  • No further medication is allowed until visit 6, except for emergencies

Exclusion Criteria

  • Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
  • Uncorrected hypertension (screening: >139 systolic or >89 diastolic)
  • Women who are pregnant or breast feeding or intend to become pregnant during the study
  • Lack of safe contraception for women of childbearing potential
  • Known or suspected non-compliance
  • Inability to follow study procedures (e.g., due to language problems, psychological disorders, dementia)
  • Previous enrolment into the current study
  • Enrolment of the investigator, family members, employees or dependent persons
  • Lifetime history of bipolar disorder (I, II, NOS), lifetime history of schizophrenia, schizoaffective disorder, or psychosis NOS
  • History of DSM-IV drug dependence other than alcohol (except caffeine or nicotine) within two months prior to enrolment
  • Comorbid Axis I anxiety and depression disorders and PTSD permitted only if they do not require current treatment
  • Family history of schizophrenia or schizoaffective disorder, or bipolar disorder type 1 (first or second degree relatives)
  • Violent behaviour within last 2 years or history of suicidal behaviour
  • Lifetime history of hallucinogen use on more than 10 occasions within last 10 years
  • Receiving psychotherapeutic or psychological treatment from third parties during the study is forbidden
  • Abnormal electrocardiogram
  • Any unstable illness as determined by history or laboratory tests
  • BMI <17 or >30
  • Uncorrected hypo- or hyperthyroidism
  • Contraindications to MRI
  • New use or dose changes of concomitant medication without informing investigators
  • Participation in another investigational drug study within 30 days prior to enrolment
  • Taking medications known to modulate UGT enzymes; inhibitors of UGT1A9/1A10 should be discontinued ≥5 half-lives prior to dosing
  • Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors should be discontinued ≥5 half-lives prior to dosing

Study Details

Locations

Psychiatrische Universitätsklinik Zürich — Zurich, Switzerland

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