Clinical TrialAlcohol Use Disorder (AUD)PsilocybinPsilocybinRecruiting

Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder (PAP-AUD)

This randomised, controlled clinical trial (n=128) aims to investigate whether a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with alcohol use disorder (AUD).

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

Detailed Description

Randomised, parallel-group Phase II trial (n=128) comparing a single oral high dose (25 mg) versus low dose (1 mg) of PEX010 (psilocybin) given 24 hours before a course of motivational enhancement therapy (MET) to reduce heavy drinking in patients with AUD.

All participants complete baseline clinical, behavioural and neuroimaging measures; dosing is followed by five weekly MET sessions starting 24 hours post-dose. Outcomes include percent heavy drinking days (TLFB) at 1, 4 and 12 weeks and repeat neuroimaging at 1 week.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

5 sessions

Therapeutic Protocol

mi

Study Arms & Interventions

High dose

experimental

PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Interventions

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

    PEX010 (25 mg)

Low dose

active comparator

PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    PEX010 (1 mg)

Participants

Ages
22 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Meets DSM-5 AUD criteria of at least moderate severity
  • Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
  • Desire to decrease alcohol consumption
  • Limited lifetime hallucinogen use

Exclusion Criteria

  • Exclusion Criteria:
  • Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
  • Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
  • Active suicidal ideation or serious attempt within past 3 years
  • Currently pregnant, nursing, or trying to become pregnant
  • Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test

Study Details

Locations

University of Calgary — Calgary, Alberta, Canada

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