Theoretical Background and Rationale:

Contemporary psychedelic-assisted therapy (PAT) trials have taken place in outpatient settings. However, introducing PAT in inpatient settings is relevant for conditions requiring pre-treatment withdrawal, safety issues and the provision of therapy. Additionally, in countries such as Belgium where hospitalization is conventionally proposed for difficult-to-treat psychiatric conditions, the feasibility of implementing PAT within the standard inpatient care pathway must be assessed. Here, we present the first two inpatient PAT trials in Belgium.

Research Question and Hypothesis: 

Objective:

• Assess the feasibility and preliminary clinical efficacy of implementing PAT within inpatient care.

Hypotheses: 

• It will be feasible and safe to administer PAT in an inpatient setting. 

• PAT will lead to reductions in depressive symptoms (study 1) and alcohol consumption (study 2).

Methods and Analysis: 

Study 1:
Population - treatment-resistant depression (TRD)
Design - open label feasibility study (n = 20)
Treatment - two 25mg doses of psilocybin with psychotherapeutic support, as add-on treatment to regular hospitalization for depression, including (non-)verbal group sessions. 
Primary outcome - safety and feasibility

Study 2: 
Population - severe alcohol use disorder (sAUD).
Design - randomized controlled trial (n = 62).
Treatment - one 30mg dose of psilocybin or an active placebo (5 mg of psilocybin) alongside a brief standardized psychotherapeutic intervention as part of a 4-week inpatient alcohol detoxification program. 
Primary clinical outcome - % of heavy drinking days from baseline to four weeks posthospital discharge, assessed with the timeline follow-back method. 

Conclusion: 

Research on PAT has just started in Belgium, specifically in the context of psychiatric hospitalization for TRD and sAUD