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NCT01375556 · ClinicalTrials.gov registry record · Phase 1
Genetics of the Acute Response to Alcohol in Social Drinkers
A Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01375556 is a Phase 1 study that was terminated before completion, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 33 participants.
The verdict
NCT01375556, a Phase 1 study, was terminated before completion, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ethanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-05-26 |
| Est. Completion | 2016-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01375556
The ClinicalTrials.gov registry entry for NCT01375556 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ethanol is the first listed.
NCT01375556 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01375556 about?
NCT01375556 is a clinical study titled "Genetics of the Acute Response to Alcohol in Social Drinkers". 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: \...
What is the current status of trial NCT01375556?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-05-26. Estimated completion is 2016-01-20.
What interventions are being tested in trial NCT01375556?
The interventions under investigation include: Ethanol (DRUG).
Who is sponsoring clinical trial NCT01375556?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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