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NCT01779024 · ClinicalTrials.gov registry record · Phase 2
Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01779024: Completed Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT01779024 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01779024, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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 fo
Primary Outcome
The total number of alcohol infusions self-administered.
Interventions
- DRUG Placebo
- DRUG Alcohol
- DRUG Ghrelin
- PROCEDURE fMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-12-13 |
| Est. Completion | 2017-06-01 |
| Phase | Phase 2 |
What the finished NCT01779024 record still lists
NCT01779024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01779024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01779024 about?
NCT01779024 is a clinical study titled "Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers". 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 o...
What is the current status of trial NCT01779024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2012-12-13. Estimated completion is 2017-06-01.
What interventions are being tested in trial NCT01779024?
The interventions under investigation include: Placebo (DRUG), Alcohol (DRUG), Ghrelin (DRUG), fMRI (PROCEDURE).
Who is sponsoring clinical trial NCT01779024?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01779024's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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