The Stress-Hormone System in Alcohol-Dependent Subjects

Completed

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID: NCT00536146
Run by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed: 70
Starts: 2007-09-24
Expected to finish: 2009-01-29
Last updated by the study team: 2017-07-02

Who can join

Age: 21 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

Alcohol-Dependent Subjects:
Primary psychoactive dependence disorder other than alcohol, except nicotine and caffeine.
Active diagnosis of Axis I Schizophrenia, Mood, or Anxiety Disorders (except PTSD).
Use of medications known to significantly affect HPA axis functioning or neural activity, including all psychotropics with the previous two weeks (or four weeks for fluoxetine).
Use of medications known to significantly affect HPA axis functioning or neural activity, including all psychotropics with the previous two weeks (or four weeks for fluoxetine). Patients concomitantly using anxiolytics, antidepressants, opioids, lithium, anticonvulsants, sedative/hypnotics, buspirone, beta blockers, alpha adrenergic drugs, steroids, beta agonists, clonidine, dopamine agonists, naltrexone, acamprosate, or disulfiram will be excluded from the study.
Any medical conditions that might affect HPA axis functioning or possibly endanger the patient's health or behavioral stability. Medical conditions that might limit cooperation (e.g. dementia) or put the patient at medical risk (i.e. significant hematologic, hepatic, renal, or cardiovascular pathology) will be excluded. Patients with past or present neurologic disorders (i.e. head trauma with loss of consciousness requiring hospitalization, transient ischemic attacks, stroke, tumor, etc.) will be excluded.
Healthy Controls:
Lifetime history of DSM IV Substance Use Disorder (except Nicotine or Caffeine Dependence) or other Axis I disorder.
One first-degree family member with a substance use disorder (other than nicotine).
Medical, psychiatric, and medication exclusions will be the same as those described for the alcohol dependent patients.

Where it is running

University of Texas Southwestern Medical Center — Dallas, Texas, United States
Veterans Affairs Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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