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Terminated Phase 1 Interventional Accepts healthy volunteers

Genetics of the Acute Response to Alcohol in Social Drinkers

ClinicalTrials.gov ID: NCT01375556

Public ClinicalTrials.gov record NCT01375556. 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 5, 2026, 1:39 AM EDT

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

Official title

Genetics of the Acute Response to Alcohol in Humans

Brief summary

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

Background: \- Previous research has shown that a person s genes can influence how they respond to alcohol. But researchers do not yet know all the genes that might be involved. Objectives: \- To identify genes that are related to how non-alcoholic individuals respond to alcohol. Eligibility: \- Healthy people between 21 and 30 years of age who have no history of alcohol or drug dependence. Design: * The study requires one or two 9-hour visits to the National Institutes of Health Clinical Center. * Participants must not take any medicines (except birth-control pills for women) for at least 3 days before the visit. They must not drink alcohol for at least 2 days before the visit. * Screening includes a medical history, physical exam, and a urine test for drugs of abuse. * Participants will be given alcohol over about 2.5 hours. This will have about the same effect as having three to four drinks. Frequent breathalyzer tests will check breath alcohol level during the infusion. * Before and during the infusion, participants will complete questionnaires about mood and feelings. Other tests will study thinking, balance, judgment, and risk-taking. Blood samples will be collected four times during the infusion. * Participants will have breakfast at the start of the visit (around 8:00 AM). They will have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be served after the alcohol infusion is complete (around 2:20 PM). After the tests, those in the study will have to stay in the Clinical Center until their breath alcohol level falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at that time. Participants will not be able to drive themselves home after the study visits. Also, they should not take any medicines or operate any machinery for at least 2 hours after leaving NIH.

Study identification

NCT ID
NCT01375556
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Enrollment
33 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
21 Years to 30 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
May 25, 2011
Primary completion
Jan 19, 2016
Completion
Jan 19, 2016
Last update posted
Nov 28, 2019

2011 – 2016

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 NCT01375556, 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 Nov 28, 2019 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01375556 live on ClinicalTrials.gov.

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