Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

Summary

Background:

\- Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes people feel hungry, and also is connected with the desire to drink alcohol. Researchers want to test ghrelin to see if it can be used to control alcohol cravings and use. They will compare doses of ghrelin with a placebo in people who drink heavily.

Objectives:

\- To study the effects of ghrelin on alcohol craving and use.

Eligibility:

* Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking treatment for alcohol use.
* Participants must on average have more than 20 drinks per week for men, and more than 15 drinks per week for women.

Design:

* Participants will have a screening visit, four 2-night study visits, and a follow-up visit.
* Participants will be screened with a physical exam and medical history. They will provide urine and breath samples for drug testing. They will also answer questions about mood and physical symptoms, and about alcohol and other cravings.
* At the study visits, participants will stay overnight at the National Institutes of Health clinical center. They will spend the night at the center, have tests on the next day, and go home on the following morning. At each visit, participants will receive a ghrelin or placebo infusion, and will complete a series of tasks.
* For the first and second study visits, participants will have tests of alcohol craving and use. They will be able to receive alcohol infusions through a computer program that tests response time and craving reactions. At the same time, they will have a ghrelin or a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied.
* For the third and fourth study visits, participants will have a magnetic resonance imaging (MRI) study. They will have an initial MRI to provide a picture of the brain. They will then have a functional MRI during which they will respond to a computer test. The test will allow them to win points for snack food or alcohol. This test will look at the brain s response time and craving reactions.
* There will be a follow-up visit 1 week after the fourth study visit. Some of the tests from the screening visit will be repeated.

Conditions

• fMRI
• Alcohol Drinking
• Alcoholism

Interventions

DRUG

Ghrelin

DRUG

Placebo

PROCEDURE

fMRI

DRUG

Alcohol

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  lead NIH

Principal Investigators

• Lorenzo Leggio, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-13

Primary Completion

2017-06-01

Completion

2017-06-01

FDA Drug

Yes

Countries

• United States

Study Locations