Background:
Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3
medicines have been approved by Food and Drug Administration to treat AUD. Researchers want
to find better treatments for AUD. Animal studies found that a medicine called
spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is
approved to treat high blood pressure, or heart failure in people. It is not approved to
treat AUD.
Objective:
To test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order
to understand how the body breaks down spironolactone and if there are any side effects in
people who drink alcohol while taking this medicine.
Eligibility:
People aged 21 and older with AUD.
Design:
Participants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months.
Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5
days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of
the medicine. The placebo capsule looks just like the spironolactone capsule but contains no
medicine. Participants will not know when they are taking the medicine or the placebo.
Participants will not drink alcohol until day 6 of each clinic stay. Then they will be asked
to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and
their well-being will be measured.
Participants will undergo other tests in the clinic:
A DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle
mass. Participants will lie on an open-top, padded table, then a small arm will scan the full
length of their body. The radiation participants will get in this study is about the same as
from one regular x-ray.
Blood tests. Participants may feel some discomfort at the site of needle entry.
Electrocardiogram. This test records the heart activity. Sensors are attached to the skin
with stickers and removed after a few minutes.
Urine tests. All urine will be collected over a 3-day period during each stay. We will
measure the amount of urine, and different hormones and salts in the urine.
Questionnaires and tasks. Participants will answer questions about their alcohol use. They
will perform tasks to test mood, craving, mental and physical coordination, and how much they
feel an effect from alcohol after drinking.