Open-label, randomised, Phase II pilot RCT (n=20) comparing psilocybin 25 mg with Visual Healing versus standard set and setting in adults with moderate–severe alcohol use disorder to assess feasibility, safety and tolerability.
This randomised, open-label, parallel-group pilot trial assigns 20 adults with moderate–severe alcohol use disorder to psilocybin 25 mg plus the Visual Healing set-and-setting platform or psilocybin 25 mg with standard set-and-setting to evaluate feasibility, safety, and tolerability.
Participants receive an initial psilocybin session (25 mg) with assigned set-and-setting and preparatory and integration counselling; four weeks later all participants receive a second 25 mg session where they may choose Visual Healing or standard procedures. Outcomes focus on adverse events, retention, and feasibility metrics.
Psilocybin 25 mg with Visual Healing set-and-setting (nature-themed VR/videos) plus prep and integration counselling; second psilocybin session at 4 weeks (participant choice of condition).
First session with Visual Healing; second session at 4 weeks (participant may choose Visual Healing or standard).
Psilocybin 25 mg with standard set-and-setting plus prep and integration counselling; second psilocybin session at 4 weeks (participant choice).
Standard set-and-setting; second session at 4 weeks (participant may choose Visual Healing or standard).