Veteran Stress and Learning Study (VSL)
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|ClinicalTrials.gov Identifier: NCT00674570|
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Posttraumatic||Drug: Hydrocortisone Drug: D-Cycloserine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder|
|Actual Study Start Date :||July 1, 2008|
|Actual Primary Completion Date :||June 1, 2017|
|Actual Study Completion Date :||June 1, 2017|
Experimental: Arm 1: Hydrocortisone
25 mg/oral one hour prior to extinction task
Experimental: Arm 2: D-Cycloserine
50 mg/oral one hour prior to extinction task
Placebo Comparator: Arm 3: Placebo
One hour prior to extinction task
- Skin Conductance Change [ Time Frame: Day 7, 9, 16 ]A Coulbourn Modular Instrument System was used. Skin conductance was measured directly by a Coulbourn Isolated Skin Conductance coupler (S71-23) using a constant .5 V through 9 mm (sensor diameter) Sensor Medics Ag/AgCl electrodes placed on the hypothenar surface of the participant's non-dominant hand. The SC electrodes were separated by 14 mm. The SC level analog signal was digitized by a Coulbourn Lablinc Analog to Digital Converter (L25-12). A Microsoft Windows-based computer system was used for sampling and storing the digitized SC signal and controlling stimulus presentations.
- Heart Rate Change [ Time Frame: Day 7, 9, 16 ]HR was recorded by standard limb electrocardiogram leads connected to a High Gain Bioamplifier (S75-01) inputting to a Coulbourn Tachometer (S77-26). Physiologic analog signals were digitized by a Coulbourn Lablinc Analog to Digital Converter (L25-12).
- Corrugator EMG Change [ Time Frame: Day 7, 9, 16 ]EMG in microvolts was. Three 4-mm (sensor diameter) Ag/AgCl electrodes were placed on the corrugator muscle/forehead. Impedance levels were kept below 10 k . The EMG signal was amplified, rectified, and filtered so as to retain the 10- to 500-Hz range, notch filtered at 60 Hz, sampled at 500-Hz, digitized for 4 s beginning with the stimulus onset and stored for analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674570
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Sabra S Inslicht, PhD||San Francisco VA Medical Center, San Francisco, CA|