The Stress-Hormone System in Alcohol-Dependent Subjects
|ClinicalTrials.gov Identifier: NCT00536146|
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : July 2, 2017
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 cosyntropin (a medicine that stimulates production of cortisol) is given through the I.V. over 1 minute.
Day 3 - oCRH 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 ovine CRH (a medicine that stimulates production of cortisol) is given through the I.V. over 1 minute.
Participants may be asked to repeat these studies 3 months later.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Trauma, Stress and Persistence of HPA Dysregulation in Alcoholism|
|Study Start Date :||September 24, 2007|
|Estimated Study Completion Date :||January 29, 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536146
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Veterans Affairs Medical Center at Dallas|
|Dallas, Texas, United States|