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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06371404
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Bavarostat — DRUG
    Up to two injections of ≤ 5 mCi \[F18\] Bavarostat

Study Details

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.

Key Dates

Start date
Jun 5, 2024
Status verified
Jul 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2031

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: PTSD
    Subjects with Post Traumatic Stress Disorder
  • Arm: AUD
    Subjects with Alcohol Use Disorder
  • Arm: PTSD & AUD
    Subjects with Post Traumatic Stress Disorder and Alcohol Use Disorder
  • Arm: HC
    Healthy Control Subjects
  • Arm: TC
    Trauma-exposed healthy control subjects.

Primary Outcome Measure

HDAC6 expression in people with Post-Traumatic Stress Disorder [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06518
Kelly Cosgrove, PhD
203-737-6969
Marc Grasso, Ba
2037377074
Kelly Cosgrove, PhD (PRINCIPAL_INVESTIGATOR)

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