Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Brief Summary

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 treatment of AUD.

Intervention / Treatment

  • Drug: Psilocybin

Condition or Disease

  • Alcohol Use Disorder (AUD)

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 20 Years to 70 Years   (Adult, Older Adult)
Enrollment: 10 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jul 01, 2022
Primary Completion: Sep 01, 2022
Completion Date: Sep 01, 2023
Study First Posted: Jan 22, 2021
Last Updated: Jun 02, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT04718792
Other IDs: PSILO4ALCO-FEASIBILITY
Study URL: https://ClinicalTrials.gov/show/NCT04718792
Last updated: Jun 13, 2022