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

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Pioglitazone

Criteria

Inclusion Criteria:

• Active alcohol use disorder (for those in the alcohol use disorder arms)

Exclusion Criteria:

• History of diabetes

• History of heart failure

• History of cirrhosis of the liver

• Elevation of liver enzymes greater than 2.5 times upper limit of normal

• History of bladder cancer

• Primary substance of abuse is something other than alcohol

• Current abnormal chest x-ray

• HIV-positive

• Renal impairment, defined as glomerular filtration rate (GFR) <60

• Current pregnancy or planning to become pregnant in the next 6 months

• Currently on pioglitazone treatment for another reason

• Contraindication to treatment with pioglitazone

• Inability to give informed consent (i.e., limited cognitive capacity)

• Non-English speaking