A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)
Status:
Suspended
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Emory University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)