drugset / Trial / NCT03060772

A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)

NCT03060772

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a single center, open-label, randomized clinical trial to determine the effect of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a cohort of otherwise healthy patients with an alcoholic use disorder from the Substance Abuse Treatment Program at the Atlanta Veterans Affairs (VA) Medical Center and randomize them to receive the usual treatment for two to four weeks or to the usual treatment plus PIO treatment for two to four weeks. There will also be a healthy control group (matched on age, gender, and smoking status) that will receive no treatment. To measure the effect of pioglitazone, participants will undergo a bronchoscopy before taking the study drug and then again 2-4 weeks later to look for changes. The bronchoscopy will allow researchers to obtain fluid from the lungs to see how well their immune cells respond to bacteria by determining phagocytic capacity.

Timeline

Start
2018-01-03
Primary completion
2020-01-28
Completion
2020-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 30 mg Oral

Indications