This pre-print, open-label study (n=10) investigates the effects of single-dose psilocybin (25mg) therapy in adults with severe alcohol use disorder (AUD). It finds significant reductions in alcohol consumption, craving, and increases in self-efficacy over 12 weeks following treatment despite notable between-participant pharmacokinetic variations.
Abstract of Single-Dose Psilocybin Therapy for Alcohol Use Disorder
“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 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 ten treatment-seeking adults (eight men and two 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 with a linear mixed model.
Results Notable between-participant pharmacokinetic variations were observed, with peak plasma psilocin concentrations ranging from 14-59 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, -13.9, p = 0.005), and drinks per day decreased by 3.4 units (95% CI: -6.5, -0.3), p = 0.035). 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.”
Authors: Mathias E. Jensen, Dea S. Stenbæk, Catharina D. Messell, Emil D. Poulsen, Tibor V. Varga, Patrick M. Fisher, Marie K. Klose Nielsen, Sys S. Johansen, Nora D. Volkow, Gitte M. Knudsen & Anders F. Fink-Jensen
Summary of Single-Dose Psilocybin Therapy for Alcohol Use Disorder
Psilocybin, a compound found naturally in certain mushroom species, has shown promising effects in treating alcohol use disorder (AUD). This builds on early research from the 1950s and 60s that investigated LSD, a structurally similar compound, for treating alcoholism. While those early studies lacked modern scientific rigour, a recent meta-analysis of six randomised controlled trials from that era found long-term benefits of a single LSD dose on alcohol misuse and abstinence.
Recent research has provided further support for psilocybin’s efficacy in treating AUD. Notably, these studies have consistently used a regimen involving two dosing sessions. However, several clinical studies on depression have reported positive outcomes with just one dosing session. This highlights the need to evaluate the efficacy of a single dose of psilocybin for AUD treatment.
Psilocybin can induce profound alterations in conscious experience, often mediating shifts in how people perceive themselves and the world. While the underlying therapeutic mechanisms are not fully understood, growing evidence suggests these drug-induced experiences play a key role in psilocybin’s long-term therapeutic effects. Therefore, understanding what shapes these experiences is crucial for advancing its therapeutic applications.
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https://doi.org/10.21203/rs.3.rs-4947184/v1
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Cite this paper (APA)
Jensen, M. E., Stenbæk, D. S., Messell, C. D., Poulsen, E. D., Varga, T. V., Fisher, P. M., ... & Fink-Jensen, A. (2024). Single-Dose Psilocybin Therapy for Alcohol Use Disorder: Pharmacokinetics, Feasibility, Safety, and Efficacy in an Open-Label Study.
Study details
Compounds studied
Psilocybin
Topics studied
Alcohol Use Disorder
Addiction
Study characteristics
Original
Open-Label
Participants
10
Humans
Compound Details
The psychedelics given at which dose and how many times
Psilocybin 25 mg | 1xLinked Clinical Trial
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