Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01031979
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2009-12-04
Brief Title:
Prolonged Exposure for Post Traumatic Stress Disorder PTSD WithWithout Yohimbine
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Psychophysiology of Prolonged Exposure for PTSD WithWithout Yohimbine
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study has three distinct but related research objectives The first goal is to measure physiological correlates of successful treatment with Prolonged Exposure PE therapy for posttraumatic stress disorder PTSD in veterans of the Iraq and Afghanistan wars Individuals with PTSD often experience elevated heart rates and other objectively measurable signs of anxiety when confronted with safe situations that remind them of past dangerous situations We will measure physiological responses and compare the outcomes to patients self reported subjective accounts of symptom improvement on traditional measures of PTSD Developing a way to measure objective gains in symptoms improvement may help researchers who are studying ways to improve PTSD treatment The second goal of the study is to investigate if yohimbine a drug found to promote a specific type of learning will improve treatment outcomes for veterans in PTSD treatment The third goal is to investigate if ability to get used to loud startling audio tones correlates to baseline PTSD pathology and treatment outcomes for PE This goal represents an important step forward in understanding characteristics of heritable traits that are related PTSD It is significant because such research may one day lead to the development of individual responder policies that will assist patients by individualizing treatment plans based on personal characteristics
Detailed Description:
The proposed study has three distinct but related research objectives The first research goal is to measure psychophysiological correlates of treatment gains associated with Prolonged Exposure PE therapy for PTSD in veterans of Operations Enduring Freedom and Iraqi Freedom OEFOIF Specifically heart rate heart rate variability skin conductance and facial electromyography will be recorded before and after treatment during a three minute anxiety probe specific to the patients index trauma These measures will be compared to patients self reported subjective accounts of symptom improvement on traditional measures of PTSD pathology Subjective Units of Distress SUDs PTSD Checklist-Military Version PCL Clinician Administered PTSD Scale CAPS and the Beck Depression Inventory BDI This goal is significant for veterans because currently no widely used objective criteria exist to measure treatment progress in PTSD While the preponderance of existing evidence suggests that no one objective psychophysiological measurement will be a valid correlate for all individuals even establishing a measurement paradigm that can show mean differences between groups will provide researchers with an objective tool to measure outcomes on clinical trials
The second goal of the study is to investigate if the administration of yohimbine a drug found to promote the extinction of conditioned fear in animal models and more recently in humans with claustrophobia improves the facilitation of fear extinction in PE Yohimbine is a safe drug that is already extensively used in human populations Specifically this goal will be investigated using a double blind placebo controlled randomized trial design The hypothesis is that one 21mg oral dose of yohimbine given concurrently with a 40 minute imaginal exposure exercise in PE will lead to a greater reduction in cue-induced anxiety during the following weekly PE session than placebo This goal is significant because current projections of PTSD in OEFOIF veterans indicate that the need for psychological services will likely outpace the supply of such services Accordingly assisting treatments to be more efficient will likely translate into more veterans receiving much needed mental health services
The 3rd goal is to investigate if ability to habituate to loud 95db audio tones correlates to baseline PTSD pathology and treatment outcomes for PE This goal represents an important step forward in understanding characteristics of trait habituation fear extinction and learning in humans which are all factors related to the successful treatment of PTSD It is also significant because such research may lead to the development of individual responder policies that will assist veterans by individualizing treatment plans based on personal characteristics
The second goal of the study is to investigate if the administration of yohimbine a drug found to promote the extinction of conditioned fear in animal models and more recently in humans with claustrophobia improves the facilitation of fear extinction in PE Yohimbine is a safe drug that is already extensively used in human populations Specifically this goal will be investigated using a double blind placebo controlled randomized trial design The hypothesis is that one 21mg oral dose of yohimbine given concurrently with a 40 minute imaginal exposure exercise in PE will lead to a greater reduction in cue-induced anxiety during the following weekly PE session than placebo This goal is significant because current projections of PTSD in OEFOIF veterans indicate that the need for psychological services will likely outpace the supply of such services Accordingly assisting treatments to be more efficient will likely translate into more veterans receiving much needed mental health services
The 3rd goal is to investigate if ability to habituate to loud 95db audio tones correlates to baseline PTSD pathology and treatment outcomes for PE This goal represents an important step forward in understanding characteristics of trait habituation fear extinction and learning in humans which are all factors related to the successful treatment of PTSD It is also significant because such research may lead to the development of individual responder policies that will assist veterans by individualizing treatment plans based on personal characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None