MYCOLab Ai Logo - gold and army green

Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial

Summary

This study tests whether psilocybin (the active compound in magic mushrooms) combined with therapy can help people with severe alcohol addiction reduce drinking. Participants receive either a high or low dose of psilocybin during a guided session as part of a hospital rehabilitation program. The researchers will measure changes in drinking behavior, mood, anxiety, and brain function to determine if this treatment works better than current options.

Background

Alcohol use disorder affects approximately 5% of the global population with over 50% of patients relapsing within one month of cessation using current treatments. Psilocybin-assisted therapy has shown promising preliminary results in treating alcohol use disorder, with historical LSD studies and recent psilocybin trials demonstrating greater efficacy than standard medications. This study aims to evaluate psilocybin-assisted therapy as an auxiliary intervention during inpatient rehabilitation for severe alcohol use disorder.

Objective

The primary objective is to evaluate the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy integrated into a 4-week inpatient rehabilitation program for severe alcohol use disorder. The study also aims to identify modifications in neurocognitive systems underlying addiction, particularly those involved in reward processing and behavioral inhibition.

Results

This is a protocol paper describing planned methodology; results are not yet available. The study is expected to complete by autumn 2026.

Conclusion

This pragmatic trial addresses key limitations in existing psilocybin research for alcohol use disorder by targeting patients with severe symptoms, maintaining rigorous blinding with an active placebo condition, and systematically investigating neurocognitive mechanisms. The integration of psilocybin-assisted therapy within existing clinical care pathways provides real-world evidence for feasibility and efficacy.
  • Published in:BMC Psychiatry,
  • Study Type:Clinical Trial - Phase II Protocol,
  • Source: 10.1186/s12888-024-05502-y, PMID: 38279085
Scroll to Top