Background:
- Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is
mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate
alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to
know if people can tolerate a particular drug that blocks ghrelin. It will be given at two
dose levels, combined with alcohol.
Objective:
- To determine if a drug that may decrease alcohol consumption when given along with alcohol
is safe and tolerable.
Eligibility:
- Healthy adults 21-65 years old who have 14 (women) to 21 (men) drinks a week.
- No one of childbearing potential can participate.
Design:
- Participants will have 3 inpatient clinic visits; each will last 4 days.
- They will have physical exam and blood and urine tests.
- They will have breath tests for alcohol and smoking.
- They will answer health and mood questions.
- Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.
- They will eat only the food provided by the clinic. They will keep a food diary 1 day
before each stay.
- They will be randomly assigned to take the study drug or placebo 5 times each stay.
- On Day 3, they will drink alcohol after taking the drug. They will give many blood
samples that day through a tube inserted in their skin.
- Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.
- One week after the last stay, participants will have a follow-up visit to answer
questions.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators:
National Center for Advancing Translational Science (NCATS) University of Rhode Island