NCT06371404

Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 \[18F\]Bavarostat 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 \[18F\]Bavarostat 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 \[18F\]Bavarostat 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.

Conditions

• Alcohol Use Disorder
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Bavarostat	Up to two injections of ≤ 5 mCi \[F18\] Bavarostat

Timeline

• Start date: 2024-06-05
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2024-04-17
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study