Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

This Phase II (n=60) will investigate if psilocybin (single-dose, 25mg), in combination with a withdrawal treatment (taking place in the 6 weeks before psilocybin administration), will have beneficial effects over the treatment alone.

The study will track the level of drinking, changes in brain measures (fMRI), and a variety of blood measures.

Topic Addiction Alcohol Use Disorder
Compound Placebo Psilocybin
Country Switzerland
Visit trial
Status Recruiting
Results Published
Start date 08 June 2020
End date 31 December 2023
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex Female
Age 18- 60
Therapy No

Trial Details

Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs). Of all the diseases, conditions, and injuries attributable to alcohol use, alcohol use disorders (AUDs) create the largest health burden globally. However, approved pharmacological treatments for alcoholism are limited in their effectiveness. A recent proof of- concept study testing psilocybin in ten alcohol dependent patients provides encouraging efficacy results and safety data. The investigators, therefore, propose to test the efficacy of psilocybin for treating alcohol use disorder and study its underlying neurobiological mechanisms in a randomized, placebo controlled, double blind study. To evaluate effects of psilocybin on alcohol use behaviour, clinical symptoms, neurocognitive and emotional measures in patients with alcohol use disorder. The present clinical trial aims at investigation the clinical and mechanistic effects of Psilocybin in Alcohol Addicted Patients. Patients with alcohol use disorder who have undergone withdrawal treatment within the last 6 weeks will be investigated in a single-centre, double-blind, placebo-controlled, parallel-group design clinical trial contrasting the acute and persisting effects of psilocybin to those of placebo. Patients will be randomly assigned to psilocybin or placebo group with a 1:1 allocation ratio. The study comprises a total of 6 visits during 6 weeks and two follow-up online surveys (3 and 6 months after treatment). In addition, two follow-up surveys that can be completed from home will guarantee monitoring of long-lasting changes in symptomology and ensure all potential side-effects can be captured. On the treatment visit, a single dose of psilocybin (25mg) or placebo will be administered. Patients will be monitored until all effects have worn off.

NCT Number NCT04141501

Sponsors & Collaborators

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

University of Zurich
Within the Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich, Dr Mialn Scheidegger is leading team conducting psychedelic research and therapy development.

Schweizerischer Nationalfonds
This company doesn't have a full profile yet, it is linked to a clinical trial.

Data attribution

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