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Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

NCT04718792 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-12

No results posted yet for this study

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)

Interventions

DRUG

Psilocybin

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)

Sponsors & Collaborators

  • The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet

    collaborator UNKNOWN

  • Anders Fink-Jensen, MD, DMSci

    lead OTHER

Principal Investigators

  • Anders Fink-Jensen, Professor · Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2024-07-21
Completion
2024-07-21

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718792 on ClinicalTrials.gov