Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

NCT04718792 | Active Not Recruiting Phase 2

• 1 other identifier: PSILO4ALCO-FEASIBILITY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.

Conditions

Alcohol Use Disorder (AUD)

Keywords

psilocybin; alcohol use disorder; psychedelics; addiction; pharmacokinetics; psilocin; feasibility

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder

  Assessment of the incidence and severity of expected and unexpected adverse events

  12 week after drug administration

Secondary Outcomes (25)

• Feasibility: Proportion of participants who complete

  1 week after drug administration

• Pharmacokinetic parameter of psilocin: Cmax

  From drug administration and 360 minutes after.

• Pharmacokinetic parameter of psilocin: Tmax

  From drug administration to 360 minutes after.

• Pharmacokinetic parameter of psilocin: AUC

  From drug administration to 360 minutes after.

• Pharmacokinetic parameter of brain-derived neurotropic factor

  From drug administration to 360 minutes after and 1 week after

Study Arms (1)

Psilocybin

EXPERIMENTAL

10 patients will receive a single administration of psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

A single administration of PEX010 (psilocybin 25 mg, opaque capsule for oral ingestion). PEX010 contains psilocybin (25 mg) naturally extracted from Psilocybe cubensis mushroom fruiting bodies, manufactured under current Good Manufacturing Practices (cGMP)

Psilocybin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
• History of delirium tremens or alcohol withdrawal seizures.
• History of suicide attempt or present suicidal ideation.
• Present or former severe neurological disease including head trauma with loss of consciousness \> 30 min.
• Impaired hepatic function (liver transaminases \> 3 times upper normal limit).
• Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
• Abnormal electrocardiogram
• Impaired renal function (eGFR \< 50 ml/min).
• Uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg).
• 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.
• Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
• Hypersensitivity to the active substance or to any of the excipients.
• Unable to speak and/or understand Danish.
• Any condition that the investigator feels would interfere with trial participation.

Sponsors & Collaborators

• Anders Fink-Jensen, MD, DMSci: lead
• The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet: collaborator

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Jensen ME, Stenbaek DS, Messell CD, Poulsen ED, Varga TV, Fisher PM, Nielsen MKK, Johansen SS, Volkow ND, Knudsen GM, Fink-Jensen A. Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study. J Psychopharmacol. 2025 May;39(5):463-473. doi: 10.1177/02698811251319457. Epub 2025 Feb 28.

  PMID: 40018886 DERIVED

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anders Fink-Jensen, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Open label study

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 22, 2021
• Study Start: February 9, 2023
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

DK (1)