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Veteran Stress and Learning Study (VSL)

Primary Purpose

Stress Disorders, Posttraumatic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone
D-Cycloserine
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress Disorders, Posttraumatic focused on measuring Stress Disorders, Posttraumatic, Hydrocortisone, Cycloserine, Extinction, Psychological, PTSD, San Francisco

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: Hydrocortisone

Arm 2: D-Cycloserine

Arm 3: Placebo

Arm Description

Hydrocortisone

D-Cycloserine

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2008
Last Updated
May 28, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00674570
Brief Title
Veteran Stress and Learning Study
Acronym
VSL
Official Title
Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 13, 2009 (Actual)
Primary Completion Date
June 22, 2015 (Actual)
Study Completion Date
June 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Posttraumatic
Keywords
Stress Disorders, Posttraumatic, Hydrocortisone, Cycloserine, Extinction, Psychological, PTSD, San Francisco

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Hydrocortisone
Arm Type
Experimental
Arm Description
Hydrocortisone
Arm Title
Arm 2: D-Cycloserine
Arm Type
Experimental
Arm Description
D-Cycloserine
Arm Title
Arm 3: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
25 mg/oral one hour prior to extinction task
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Intervention Description
50 mg/oral one hour prior to extinction task
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One hour prior to extinction task
Primary Outcome Measure Information:
Title
Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
Description
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.
Time Frame
15 minute measurement intervals on Study Days 7, 9, and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabra S Inslicht, PhD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28675471
Citation
Alexandra Kredlow M, Pineles SL, Inslicht SS, Marin MF, Milad MR, Otto MW, Orr SP. Assessment of skin conductance in African American and Non-African American participants in studies of conditioned fear. Psychophysiology. 2017 Nov;54(11):1741-1754. doi: 10.1111/psyp.12909. Epub 2017 Jul 4.
Results Reference
background
PubMed Identifier
23107307
Citation
Inslicht SS, Metzler TJ, Garcia NM, Pineles SL, Milad MR, Orr SP, Marmar CR, Neylan TC. Sex differences in fear conditioning in posttraumatic stress disorder. J Psychiatr Res. 2013 Jan;47(1):64-71. doi: 10.1016/j.jpsychires.2012.08.027. Epub 2012 Oct 26.
Results Reference
background
PubMed Identifier
35141873
Citation
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
Results Reference
derived

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Veteran Stress and Learning Study

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