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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Texas |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00244335 |
Post-traumatic stress disorder (PTSD) is a serious illness, in which individuals often experience anxiety and stress. Some individuals with PTSD use drugs to alleviate emotional distress. This study will examine the role that negative emotional states play in sedative drug use among individuals with PTSD.
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Emotional Control of Sedative Self-Medication in Post-Traumatic Stress Disorder |
Enrollment: | 39 |
Study Start Date: | October 2000 |
Study Completion Date: | July 2008 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
PTSD Subjects
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2
Trauma Controls: subjects who have experienced a trauma but never developed PTSD
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PTSD is a psychiatric illness that occurs following a traumatic event in which there was threat of injury or death to an individual. Common symptoms of PTSD include anxiety, stress, and tension. Some individuals with PTSD use benzodiazepines, a type of sedative medication, or alcohol to alleviate the anxiety associated with the disorder. Past research has shown that the negative feelings experienced by individuals with PTSD may increase the reinforcing effects of antidepressant drugs. Feelings of anxiety act as a stimulus, which leads to drug use; in turn, the anticipated or actual decrease in distress reinforces the drug-taking behavior. Greater amounts of sedative drugs are then needed to decrease subsequent stress and anxiety. The purpose of this study is to understand how negative emotional states affect the reinforcing effects of sedative drugs in individuals with PTSD.
This study will enroll two types of individuals, both of whom have been exposed to an emotional trauma and report using alcohol to reduce emotional distress but who differ in their subsequent development of PTSD. Participants will take part in an initial screening session which will include a physical examination, standardized psychological questionnaires, and review of medical and drug histories. Once enrolled, each participant will take part in 8 experimental session days, with each day of testing separated by at least 48 hours. At the beginning of each session, a breathalyzer and urine test will be used to screen for the presence of alcohol and drugs. On Day 1, participants will take part in an orientation session to familiarize themselves with the laboratory and study procedures. On Days 2 through 4, participants will receive varying doses of alcohol, a placebo drink, a placebo drug, and alprazolam, a type of benzodiazepine medication. On Days 5 through 8, participants will take part in experimental challenges designed to induce various emotional states, including arousal, anxiety, aggression, and anger. They will also complete a monetary reward task to measure the reinforcing effects of drugs. Participants will complete questionnaires several times each day to assess anxiety, anger, drug effects, and drug cravings. Heart rate will be monitored with an electrocardiogram, and electrodes placed on the skin will measure other physiologic measures throughout each session. Participants will receive compensation for completing each experimental session.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
PTSD subjects and subjects who have experienced a trauma but never developed PTSD (Trauma Controls) are being recruited for this study. Recruitment is being conducted through Audie L. Murphy Veterans Administration Hospital and the University of Texas Health Science Center at San Antonio.
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
University of Texas Health Science Center, San Antonio | |
San Antonio, Texas, United States, 78284 |
Principal Investigator: | John Casada, MD | University of Texas Health Science Center, San Antonio |
Responsible Party: | University of Texas Health Science Center at San Antonio ( John Casada, MD, PhD/Pedro Delgado, MD, Chairman ) |
Study ID Numbers: | NIDA-00507-1, K08-00507-1, DPMC |
Study First Received: | October 25, 2005 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00244335 |
Health Authority: | United States: Federal Government |
Post-Traumatic Stress Disorders PTSD |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease |