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Completed

NCT Number: NCT00674570

Veteran Stress and Learning Study

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.

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Key information

Conditions

Stress Disorders, Posttraumatic Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

25 mg/oral one hour prior to extinction task

D-cycloserine

Drug

50 mg/oral one hour prior to extinction task

Placebo

Drug

One hour prior to extinction task

Primary outcomes

  1. Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)

    Time frame: 15 minute measurement intervals on Study Days 7, 9, and 16

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: VSL

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 8, 2008
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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