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).
In November 2022, the protocol for the trial was published and is available for anyone to read.
Compound Psilocybin
Country Denmark
Visit trial
Status
Recruiting
Results Published
No
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 CopenhagenThe 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.