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 the treatment of AUD.
Compound Psilocybin
Country Denmark
Visit trial
Status
Not yet recruiting
Results Published
No
Start date
20 January 2021
End date
01 September 2023
Chance of happening
90%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
10
Sex
All
Age
20- 70
Therapy
Yes
Trial Details
The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per in- and exclusion criteria and baseline values will be recorded as per outcome measures. All patients will receive a single administration of 25 mg of psilocybin. As per safety guidelines patients will be monitored the entire dosing session by study staff familiar with the psychedelic effects of psilocybin. In addition, the patients will meet before and after the dosing session with a psychologist connected to the study for preparation and post-session debriefing, respectively. During dosing session, the investigators will collect blood plasma psilocin levels in order to establish pharmacokinetics and an estimated brain 5-HT2AR occupancy. When the effects of psilocybin subside, the investigators will ask the patients to fill out questionnaires encapsulating the psychedelic experience. One week after drug administration the patients are required to meet for an end-of-study assessment of outcome measures including adverse events.NCT Number NCT04718792
Sponsors & Collaborators
Copenhagen University Hospital RigshospitaletThe 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.