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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Willing and able to give voluntary written informed consent

• Is able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff

• Men or women, aged 18 to 70, at screening

• In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests

• Participants with PTSD will have a current diagnosis of PTSD according to DSM-5 criteria (CAPS-5 ascertained diagnosis, confirmed by the Principal Investigators. TC subjects must have a DSM-5 criteria traumatic event with no PTSD diagnosis

• Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., SCID-5 ascertained diagnosis, confirmed by the Principal Investigators);

• Participants with AUD will meet the following drinking criteria: males will drink \> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake.

• Healthy subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., \>4 drinks/day for men; \>3 drinks/day for women) in the last 30 days;

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Kelly Cosgrove
kelly.cosgrove@yale.edu
2037376969
Backup
Marc Grasso, Ba
marc.grasso@yale.edu
2037377074
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2031-06-01
Participants
Target number of participants: 150
Treatments
PTSD
Subjects with Post Traumatic Stress Disorder
AUD
Subjects with Alcohol Use Disorder
PTSD & AUD
Subjects with Post Traumatic Stress Disorder and Alcohol Use Disorder
HC
Healthy Control Subjects
TC
Trauma-exposed healthy control subjects.
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This content was sourced from clinicaltrials.gov

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