Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).

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Status Not yet recruiting
Start date 10 October 2022
End date 01 January 2025
Chance of happening 85%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 90
Sex All
Age 20- 70
Therapy Yes

Trial Details

To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagnosed with alcohol use disorder and treatment seeking will be recruited from the community via advertisement and referrals from general practitioners and hospital units. The psilocybin or placebo is administered within a protocol of psychological support before, during and after the dosing. Outcome assessments will be carried out one, four, eight- and 12 weeks post dosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes include 1) phosphatidyl-ethanol as an objective biomarker for alcohol consumption 2) plasma psilocin, the active metabolite, to establish a possible therapeutic range and 3) the acute subjective drug experience as a possible predictor of treatment outcome. Furthermore, we will investigate the neurobiological underpinnings of the possible treatment effects by use of functional magnetic resonance brain imaging one week post dosing.

NCT Number NCT05416229

Sponsors & Collaborators

University of Copenhagen
The Neurobiology Research Unit (NRU) at Copenhagen University Hospital have been carrying clinical and preclinical research with psychedelics since 2017.

Copenhagen University Hospital Rigshospitalet
The university hospital in Copenhagen, the Rigshospitalet, is Denmark's most prestigious (and largest) hospital. Literally translated, the name stands for 'Hospital of the Realm.' Researchers here are working on at least three psychedelic trials with psilocybin.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.
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