Status:
COMPLETED
Examining the Role of Negative Emotional States on Sedative Drug Use in Individuals With Post-Traumatic Stress Disorder
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-60 years
Brief Summary
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 w...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD with anxiety symptoms, as determined by a score greater than 14 on the Hamilton Anxiety Rating Scale, or a score greater than 18 on the Profile of Mood States-Tension Anxiety Rating Scale
- Experiences frequent and intense PTSD symptoms
- Able to spend 6 hours at a time in the research laboratory
- If a trauma control participant, must have experienced a trauma that meets criterion A for PTSD, but has never developed PTSD
- Willing to use contraception throughout the study
Exclusion
- Females who meet DSM-IV diagnostic criteria for premenstrual dysphoric disorder
- Females who report premenstrual distress that motivates them to use alcohol for relief
- History of bipolar affective disorder, any psychotic disorder, current major depressive episode, or current primary non-PTSD anxiety disorder (individuals with Axis II diagnoses will not be excluded)
- Currently enrolled in psychodynamic or cognitive-behavioral therapy
- Current unstable medical illness
- Current medical illness treated with psychoactive drugs (e.g., beta blockers)
- Current medical illness with complicating psychiatric symptoms (e.g., thyroid disease)
- Requires use of certain medications
- Current or past history of illicit substance dependence, other than past marijuana abuse or dependence
- History of tobacco dependence
- Failure to provide a drug-free urine sample prior to study entry
- Smokes more than one pack of cigarettes per day or drinks beverages totaling more than 500 mg of caffeine per day
- Pregnant
Key Trial Info
Start Date :
October 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00244335
Start Date
October 1 2000
End Date
July 1 2008
Last Update
January 10 2017
Active Locations (1)
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1
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States, 78284