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Completed Phase 1 Interventional

A Novel Compound for Alcoholism Treatment

ClinicalTrials.gov ID: NCT02039349

Public ClinicalTrials.gov record NCT02039349. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 4:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Novel Compound for Alcoholism Treatment: A Translational Strategy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02039349
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
14 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2, 2014
Primary completion
Sep 30, 2015
Completion
Dec 23, 2017
Last update posted
Dec 15, 2019

2014 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02039349, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 15, 2019 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02039349 live on ClinicalTrials.gov.

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