Veteran Stress and Learning Study

Study Overview
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Brief Summary
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This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.

Official Title
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Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder

Conditions
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Stress Disorders, Posttraumatic

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: D-Cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans and civilians with an age range of 18 to 65 years Participants must be physically healthy volunteers Exclusion Criteria: Individuals who fall outside the age range Individuals with medical conditions that would interfere with participation Other criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Hydrocortisone<br>Hydrocortisone | Drug: Hydrocortisone<br>* 25 mg/oral one hour prior to extinction task<br>|
| Experimental: Arm 2: D-Cycloserine<br>D-Cycloserine | Drug: D-Cycloserine<br>* 50 mg/oral one hour prior to extinction task<br>|
| Placebo Comparator: Arm 3: Placebo<br>Placebo | Drug: Placebo<br>* One hour prior to extinction task<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS) | Psychophysiology measurements occurred on day 7 for fear conditioning, day 9 for fear extinction, and day 11 for extinction retention. The primary outcome measures are presented for the first and last conditioned stimulus (CS) trials during fear conditioning and extinction and for the first 2 trials during retention. Conditioned Responses (CR): An SCR score was obtained for each CS by subtracting the mean skin conductance level (SCL) in microsiemens (µS) for the 2-s interval immediately preceding CS onset from the max SC level in µS during the 8-s CS presentation. Unconditioned Response (UCR): An SCR score for the UCR was obtained by subtracting the mean SCL in µS within 6-8 s following CS offset from the max increase in SC level during the .5-6.5 time interval following the CS offset, corresponding to the onset of the .5s US. SC responses were range corrected using each participant's maximum response to the UCS or CS during acquisition trials of the fear conditioning phase. | 15 minute measurement intervals on Study Days 7, 9, and 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Disorders, Posttraumatic, Hydrocortisone, Cycloserine, Extinction, Psychological, PTSD, San Francisco