Clinical TrialAlcohol Use Disorder (AUD)PsilocybinActive not recruiting

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Open-label, single-group Phase II feasibility study (n=10) administering a single oral dose of psilocybin 25 mg to people with alcohol use disorder to assess safety, feasibility and psilocin pharmacokinetics.

Target Enrollment
10 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label single-group study will give a single oral dose of PEX010 (psilocybin 25 mg) to 10 participants with alcohol use disorder to assess feasibility and safety.

Participants will meet with a psychologist for preparation and post-session debriefing; blood samples will be taken during the dosing session to establish psilocin pharmacokinetics and estimated 5-HT2A receptor occupancy, and outcomes including adverse events will be assessed at one week.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions

Integration

1 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Single-group open-label administration of psilocybin 25 mg (PEX010) to participants with AUD.

Interventions

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

    PEX010 psilocybin 25 mg opaque capsule, cGMP

Participants

Ages
20 – 70
Sexes
Male & Female

Inclusion Criteria

  • 1. Age of 20-70 years (both included).
  • 2. Body weight of 60-95 kg (both included).
  • 3. Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
  • 4. Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
  • 5. ≥ 5 heavy drinking days.

Exclusion Criteria

  • 1. Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
  • 2. History of delirium tremens or alcohol withdrawal seizures.
  • 3. History of suicide attempt or present suicidal ideation.
  • 4. Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
  • 5. Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
  • 6. Impaired hepatic function (liver transaminases > 3 times upper normal limit).
  • 7. Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
  • 8. Abnormal electrocardiogram.
  • 9. Impaired renal function (eGFR < 50 ml/min).
  • 10. Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
  • 11. Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
  • 12. Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
  • 13. Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
  • 14. Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective.
  • 15. Hypersensitivity to the active substance or to any of the excipients.
  • 16. Unable to speak and/or understand Danish.
  • 17. Any condition that the investigator feels would interfere with trial participation.

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2021-01-20
    End: 2023-09-01
  • Compound
    Psilocybin
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Psychiatric Center Copenhagen — Copenhagen, Frederiksberg, Denmark

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