TY - JOUR
T1 - Single-dose psilocybin therapy for alcohol use disorder
T2 - Pharmacokinetics, feasibility, safety and efficacy in an open-label study
AU - Jensen, Mathias Ebbesen
AU - Stenbæk, Dea Siggaard
AU - Messell, Catharina Dragsted
AU - Poulsen, Emil Deleuran
AU - Varga, Tibor V
AU - Fisher, Patrick McDonald
AU - Nielsen, Marie Katrine Klose
AU - Johansen, Sys Stybe
AU - Volkow, Nora D
AU - Knudsen, Gitte Moos
AU - Fink-Jensen, Anders
PY - 2025
Y1 - 2025
N2 - BACKGROUND: Psilocybin, a serotonin 2A receptor agonist with psychedelic properties, shows promise as a novel treatment for alcohol use disorder (AUD). While current studies involve two dosing sessions, the effects of a single dose have not been investigated.AIMS: To investigate the pharmacokinetics, feasibility, safety and efficacy of single-dose psilocybin therapy in AUD.METHODS: This open-label, single-group study investigated single-dose psilocybin therapy in 10 treatment-seeking adults (8 men and 2 women; median age 44 years) with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session (25 mg) and two integration sessions. Pharmacokinetics were determined by noncompartmental analysis, and changes in alcohol consumption, craving and self-efficacy, were assessed using a linear mixed model.RESULTS: Notable between-participant pharmacokinetic variations were observed, with peak plasma psilocin concentrations ranging from 14 to 59 µg/L. Alcohol consumption significantly decreased over the 12 weeks following psilocybin administration. Heavy drinking days were reduced by 37.5 percentage points (95% CI: -61.1 to -13.9,
p = 0.005), and drinks per day decreased by 3.4 drinks (95% CI: -6.5 to -0.3,
p = 0.03). This was corroborated by reports of rapid and sustained reductions in craving and increases in self-efficacy.
CONCLUSIONS: Despite pharmacokinetic variations, a single 25 mg psilocybin dose was safe and effective in reducing alcohol consumption in AUD patients. Larger randomised, placebo-controlled, single-dose AUD trials are warranted.CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04718792.
AB - BACKGROUND: Psilocybin, a serotonin 2A receptor agonist with psychedelic properties, shows promise as a novel treatment for alcohol use disorder (AUD). While current studies involve two dosing sessions, the effects of a single dose have not been investigated.AIMS: To investigate the pharmacokinetics, feasibility, safety and efficacy of single-dose psilocybin therapy in AUD.METHODS: This open-label, single-group study investigated single-dose psilocybin therapy in 10 treatment-seeking adults (8 men and 2 women; median age 44 years) with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session (25 mg) and two integration sessions. Pharmacokinetics were determined by noncompartmental analysis, and changes in alcohol consumption, craving and self-efficacy, were assessed using a linear mixed model.RESULTS: Notable between-participant pharmacokinetic variations were observed, with peak plasma psilocin concentrations ranging from 14 to 59 µg/L. Alcohol consumption significantly decreased over the 12 weeks following psilocybin administration. Heavy drinking days were reduced by 37.5 percentage points (95% CI: -61.1 to -13.9,
p = 0.005), and drinks per day decreased by 3.4 drinks (95% CI: -6.5 to -0.3,
p = 0.03). This was corroborated by reports of rapid and sustained reductions in craving and increases in self-efficacy.
CONCLUSIONS: Despite pharmacokinetic variations, a single 25 mg psilocybin dose was safe and effective in reducing alcohol consumption in AUD patients. Larger randomised, placebo-controlled, single-dose AUD trials are warranted.CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04718792.
U2 - 10.1177/02698811251319457
DO - 10.1177/02698811251319457
M3 - Journal article
C2 - 40018886
SN - 0269-8811
JO - Journal of psychopharmacology (Oxford, England)
JF - Journal of psychopharmacology (Oxford, England)
ER -