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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:1/18/2019
Start Date:January 3, 2018
End Date:March 20, 2019
Contact:David Guidot, MD
Email:dguidot@emory.edu
Phone:(404) 321-6111

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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.

Alcohol abuse is a major burden on society and an enormous problem in the veteran population.
Many people are aware that chronic alcohol ingestion can cause serious health problems like
liver injury and brain damage but chronic alcohol consumption can also hurt the lungs. People
who regularly drink more than the daily maximum levels recommended by the Centers for Disease
Control and Prevention (CDC) (1 drink per day for women or 2 drinks per day for men) are more
likely to suffer from pneumonia and acute lung injuries.

The primary goal of this clinical research study is to determine if a Food and Drug
Administration (FDA) approved diabetes drug, called pioglitazone, can improve the lung immune
defenses in otherwise healthy alcoholics. There is strong evidence from experimental animal
models that pioglitazone preserves lung health even during daily alcohol ingestion.

This National Institutes of Health (NIH) funded project will recruit veterans who are
patients at the Atlanta VA Hospital. Half of the participants will be randomly assigned to
receive pioglitazone and half will be assigned to receive no treatment. Participants assigned
to pioglitazone will take the pill once per day for two to four weeks. To measure the effect
of pioglitazone, participants will undergo a procedure called 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). The researchers also plan to enroll 12
healthy veteran patients who do not drink. These participants will undergo a one-time
bronchoscopy and no other visits will be required of them.

The findings from this study will guide future, larger scale clinical trials to determine if
pioglitazone can be used in the clinical setting to improve outcomes in alcoholics who
develop pneumonia or acute lung injury.

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
We found this trial at
1
site
Decatur, Georgia 30033
Principal Investigator: David Guidot, MD
Phone: 404-321-6111
?
mi
from
Decatur, GA
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