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Veteran Stress and Learning Study (VSL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674570
First Posted: May 8, 2008
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention Phase
Stress Disorders, Posttraumatic Drug: Hydrocortisone Drug: D-Cycloserine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • Eye Blink 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.


Enrollment: 138
Actual Study Start Date: July 1, 2008
Study Completion Date: June 1, 2017
Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Hydrocortisone
Hydrocortisone
Drug: Hydrocortisone
25 mg/oral one hour prior to extinction task
Experimental: Arm 2: D-Cycloserine
D-Cycloserine
Drug: D-Cycloserine
50 mg/oral one hour prior to extinction task
Placebo Comparator: Arm 3: Placebo
Placebo
Drug: Placebo
One hour prior to extinction task

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Sabra S Inslicht, PhD San Francisco VA Medical Center, San Francisco, CA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00674570     History of Changes
Other Study ID Numbers: CDA-2-037-07F
H841-31915-01A ( Other Identifier: San Francisco VAMC )
First Submitted: May 6, 2008
First Posted: May 8, 2008
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by VA Office of Research and Development:
Stress Disorders, Posttraumatic
Hydrocortisone
Cycloserine
Extinction, Psychological
PTSD
San Francisco

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Cycloserine
Anti-Inflammatory Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action