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.
Study Design
Study type: | Interventional |
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Status: | Not yet recruiting |
Study results: | No Results Available |
Age: | 20 Years to 70 Years (Adult, Older Adult) |
Enrollment: | 10 () |
Funded by: | Other |
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Clinical Trial Dates
Start date: | Jul 01, 2022 | |
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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
Location
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 |
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More Details
NCT Number: | NCT04718792 |
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Other IDs: | PSILO4ALCO-FEASIBILITY |
Study URL: | https://ClinicalTrials.gov/show/NCT04718792 |
Last updated: Jun 13, 2022