Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers
- 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.
- To study the effects of ghrelin on alcohol craving and use.
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
|Official Title:||Effects of Ghrelin on Alcohol Administration in Non-Treatment Seeking Heavy Drinkers|
- The primary measure of this study will be the breakpoint, which is the schedule (number of button presses) at which the individual stops to work for more alcohol during the PR sessions. [ Time Frame: Once per each condition (ghrelin vs. placebo) during the PR session ] [ Designated as safety issue: No ]
- fMRI BOLD signal in brain areas associated with incentive salience and areas associated with reward circuitry (including the ventral striatum) will be measured during the ?fMRI/ alcohol clamp? session. [ Time Frame: Once per each condition (ghrelin vs. placebo) during the fMRI/ alcohol clamp session ] [ Designated as safety issue: No ]
- Urge to drink [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: No ]
- Alcohol sensitivity [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: No ]
- Adverse event [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779024
|Contact: Lorenzo Leggio, M.D.||(301) 496-0000||Lorenzo.firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|