Spironolactone in Alcohol Use Disorder (SAUD)

Description

Study Description:

This study will examine pharmacokinetic (PK) and pharmacodynamic (PD) parameters of spironolactone and alcohol, during concomitant oral administration (0, 100, 200, 400 mg/day spironolactone PO), and test the safety and tolerability of spironolactone, co-administered with alcohol, in individuals with alcohol use disorder (AUD).

Objectives:

Our objective is to assess PK and PD parameters during spironolactone-alcohol co-administration, in individuals with AUD. We will also test the safety, tolerability, and potential drug-alcohol interaction.

Endpoints:

Primary Endpoint:

Spironolactone and alcohol PK during concomitant administration (0, 100, 200, and 400 mg/day spironolactone).

Secondary Endpoints:

1. Assessment of subjective and cognitive effects of acute alcohol administration during concomitant spironolactone treatment (0, 100, 200, and 400 mg/day).
2. Number and severity of adverse events (AEs) experienced, compared between placebo (0 mg/day) and all three spironolactone doses (100, 200, 400 mg/day).
3. PK characteristic of spironolactone active metabolites, canrenone, 7-alpha-thiomethylspirolactone (TMS) and 6beta-hydroxy-7alpha-thiomethylspirolactone (HTMS), before and after administration of alcohol.