Veteran Stress and Learning Study
VSL
Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
2 other identifiers
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedStudy Start
First participant enrolled
January 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2015
CompletedResults Posted
Study results publicly available
May 30, 2019
CompletedMay 30, 2019
May 1, 2019
6.4 years
May 6, 2008
March 22, 2019
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Arm 1: Hydrocortisone
EXPERIMENTALHydrocortisone
Arm 2: D-Cycloserine
EXPERIMENTALD-Cycloserine
Arm 3: Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Veterans and civilians with an age range of 18 to 65 years
- Participants must be physically healthy volunteers
You may not qualify if:
- Individuals who fall outside the age range
- Individuals with medical conditions that would interfere with participation
- Other criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121, United States
Related Publications (4)
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.
PMID: 28675471BACKGROUNDInslicht 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.
PMID: 23107307BACKGROUNDBertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PMID: 38767196DERIVEDBertolini 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.
PMID: 35141873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Technical difficulties rendered corrugator electromyogram data unusable for analysis. We selected skin conductance as a primary measure of sympathetic activity rather than heart rate, which has both sympathetic and parasympathetic influences.
Results Point of Contact
- Title
- Sabra Inslicht, Ph.D.
- Organization
- San Francisco VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Sabra S Inslicht, PhD
San Francisco VA Medical Center, San Francisco, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2008
First Posted
May 8, 2008
Study Start
January 13, 2009
Primary Completion
June 22, 2015
Study Completion
June 22, 2015
Last Updated
May 30, 2019
Results First Posted
May 30, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share