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NCT00536146 · ClinicalTrials.gov registry record

The Stress-Hormone System in Alcohol-Dependent Subjects

A clinical trial of Alcoholism, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
70
Enrollment target
2
Study locations

NCT00536146 is a study of Alcoholism that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 70 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT00536146, a study of Alcoholism, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
70 participants
Enrollment target
2
Study locations

Study Summary

This study, conducted at the University of Texas Southwestern Medical Center and the Parkland Hospital in Dallas, will examine the stress hormone system of alcohol-dependent people. This system is weakened in alcohol-addicted people. This study will determine how long it is weakened, whether other hormone systems are also weakened and whether changes in the hormone system are associated with previous trauma or stress. Healthy normal men and men who are alcohol-dependent may be eligible for this study. Candidates must be between 21 and 60 years of age and have at least a 5-year history of active alcohol dependence. They are screened with a medical history, blood and urine tests and questions about alcohol and drug use, psychiatric problems, history of trauma and recent stress. Participants undergo the following procedures: Day 1 - Public Speaking Task At 6:00 PM subjects have an I.V. line (needle attached to a small plastic tube) inserted into a vein in each arm to draw blood samples and give medication. They are then given a light dinner and then lie down and rest. They rinse their mouth out with water and a drop of lemon juice is placed on their tongue. In 30 to 40 seconds they spit into a funnel attached to a collecting tube. A blood sample is collected to measure levels of cortisol (a stress hormone) ACTH (a hormone responsible for the release of cortisol) and neurosteroids (hormones that affect the brain). Subjects then give a 5-minute speech (telling an ending to a story) and solve a math problem in front of a small group of people. They are then asked how they are feeling. Saliva and blood samples are then collected every 10 minutes for the next 60 minutes. Day 2 - Cosyntropin Study At 6:30 p.m. subjects have an I.V. line inserted into a vein in each arm. At 7:45 PM and 8:30 PM saliva is collected as described above. Starting at 7:30 PM, blood samples are collected every 10 minutes until 9:00 PM and then every 20 minutes until 10:00 PM. At 8:00 PM cosynt

Conditions Studied

Study Locations (2)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • Veterans Affairs Medical Center at Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2007-09-24
Est. Completion 2009-01-29

What the Registry Record Tells You About NCT00536146

The ClinicalTrials.gov registry entry for NCT00536146 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (81% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 0 interventions.

NCT00536146 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00536146 about?

NCT00536146 is a clinical study titled "The Stress-Hormone System in Alcohol-Dependent Subjects". This study, conducted at the University of Texas Southwestern Medical Center and the Parkland Hospital in Dallas, will examine the stress hormone system of alcohol-dependent people. This system is weakened in alcohol-addicted people. This study will determine how long it is weakened, whether other h...

What is the current status of trial NCT00536146?

This trial is currently completed. The enrollment target is 70 participants. The study started on 2007-09-24. Estimated completion is 2009-01-29.

What conditions does trial NCT00536146 study?

This clinical trial studies the following conditions: Alcoholism.

Who is sponsoring clinical trial NCT00536146?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00536146 being conducted?

This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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