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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: Completed study of Alcoholism, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2007-09-24 |
| Est. Completion | 2009-01-29 |
What the finished NCT00536146 record still lists
NCT00536146 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 0 interventions.
NCT00536146 reports a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00536146's enrollment target sits among peer trials
70 43rd of 65 higher than 21 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism 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.
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