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Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

NCT05646303 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-08-15

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are:

* Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
* Is treatment with psilocybin and therapy safe for participants?

Participants will

* Attend 13 study visits
* Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
* Record their daily alcohol consumption on study specific device

Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

Conditions

Interventions

DRUG

Psilocybin

Psilocybin and psychotherapy

DRUG

Placebo

Placebo and psychotherapy

Sponsors & Collaborators

  • Optimapharm

    collaborator INDUSTRY

  • Clairvoyant Therapeutics

    lead INDUSTRY

Principal Investigators

  • Hannu Alho, MD · Addiktum Oy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Canada
  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05646303 on ClinicalTrials.gov