Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371404
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Imaging Traumatic Stress and Alcohol Use Disorder With 18FBavarostat
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Imaging Traumatic Stress and Alcohol Use Disorder With 18FBavarostat
Status:
RECRUITING
Status Verified Date:
2024-08
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 overall objective of this study it to use Positron Emission Tomography PET brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 HDAC6 to examine HDAC6 expression in people with Post-Traumatic Stress Disorder PTSD Alcohol Use Disorder AUD or concurrent PTSD and AUD with control groups While there are a large number of studies conducted in preclinical stress and addiction models these findings have not been translated to people living with these disorders This study will examine relationships between HDAC6 and clinical variables of interest Findings could direct treatment development
Detailed Description:
This study will image 150 subjects total as outlined below Subjects will be asked to participate in magnetic resonance imaging MRI and PET imaging procedures as well as behavioral and cognitive tasks to better understand stress and alcohol related behaviors MRI is required to detect significant brain abnormalities and for use in the PET image analysis
In Aim 1 Up to 30 PTSD and 30 TC will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with PTSD have altered levels of HDAC6 expression compared to trauma-exposed healthy controls
In Aim 2 Up to 30 AUD and 30 HC will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with AUD have altered levels of HDAC6 expression compared to healthy controls
In Aim 3 Up to 30 comorbid PTSD AUD subjects will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with comorbid PTSD AUD have altered levels of HDAC6 expression compared to trauma-exposed healthy controls
In Aim 1 Up to 30 PTSD and 30 TC will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with PTSD have altered levels of HDAC6 expression compared to trauma-exposed healthy controls
In Aim 2 Up to 30 AUD and 30 HC will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with AUD have altered levels of HDAC6 expression compared to healthy controls
In Aim 3 Up to 30 comorbid PTSD AUD subjects will be imaged with 18FBavarostat to measure levels of HDAC6 throughout the brain to determine whether individuals with comorbid PTSD AUD have altered levels of HDAC6 expression compared to trauma-exposed healthy controls
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?:
None
Is an FDA AA801 Violation?:
None