Actively Recruiting
Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat
Led by Yale University · Updated on 2025-07-10
150
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give voluntary written informed consent
- Able to read, write, communicate effectively, and follow study instructions
- Men or women aged 18 to 70 at screening
- In good general health based on medical history and tests
- PTSD participants must have current PTSD diagnosis by DSM-5 criteria; trauma controls must have traumatic event without PTSD
- AUD participants must have current AUD diagnosis by DSM-5 criteria
- AUD participants must meet specific drinking criteria: males >14 drinks/week and >4 drinks/day twice weekly; females >7 drinks/week and >3 drinks/day twice weekly within 90 days prior to intake
- Healthy controls must have no current or past AUD or significant substance use disorder and drink less than 5 drinks/week with no heavy drinking days in last 30 days
You will not qualify if you...
- Current significant medical conditions affecting data integrity (e.g., neurological, cardiovascular, endocrine, renal, liver, thyroid), except elevated liver enzymes in AUD
- Past or current neurological disorders affecting the brain including multiple sclerosis, stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder
- Current severe psychiatric disorders excluding alcohol or tobacco use disorder, or past/current psychotic symptoms
- Regular use in past 6 months of medications affecting data integrity (antidepressants, antipsychotics, anxiolytics, naltrexone); no stopping medications required
- Pregnancy or lactation
- Blood donation within 8 weeks before study
- History of bleeding disorders or current use of anticoagulants
- Unable to safely stop aspirin or NSAIDs
- MRI incompatible implants or contraindications such as claustrophobia or metal fragments
- Participation in other radiation studies within one year exceeding dose limits
- Occupational radiation exposure within one year exceeding dose limits
- Any condition preventing compliance with protocol as judged by investigator
- History of complicated alcohol withdrawal including delirium tremens, seizures, or hospitalization
- Alcohol intoxication at screening
- CIWA score 8 or higher at intake or scan day
- Unable to safely abstain from alcohol overnight prior to study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06518
Actively Recruiting
Research Team
K
Kelly Cosgrove
CONTACT
M
Marc Grasso, Ba
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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