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

NCT06371404 | Recruiting DMC FDA Drug

• 2 other identifiers: 20000371291U54AA027989-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• HDAC6 expression in people with Post-Traumatic Stress Disorder

  Baseline

• HDAC6 expression in people with Alcohol use Disorder

  Baseline

Study Arms (5)

PTSD

Subjects with Post Traumatic Stress Disorder

Drug: Bavarostat

AUD

Subjects with Alcohol Use Disorder

Drug: Bavarostat

PTSD & AUD

Subjects with Post Traumatic Stress Disorder and Alcohol Use Disorder

Drug: Bavarostat

HC

Healthy Control Subjects

Drug: Bavarostat

TC

Trauma-exposed healthy control subjects.

Drug: Bavarostat

Interventions

Bavarostat DRUG

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

AUD; HC; PTSD; PTSD & AUD; TC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 150 adult male and female subjects, aged 18-70, who are in general good health, meet the inclusion criteria, and who do not meet any of the exclusion criteria will be eligible for enrollment into Aim 1, Aim 2, or Aim 3 of the study. Up to 30 PTSD and 30 TC subjects will be enrolled into Aim 1 of the study. Up to 30 AUD and 30 HC subjects will be enrolled into Aim 2 of the study. Up to 30 comorbid PTSD \& AUD subjectswill be enrolled into Aim 3 of the study.

You may qualify if:

• 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;

You may not qualify if:

• Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder;
• Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\*), and past or current psychotic symptoms,
• Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data (e.g., naltrexone); No subject will be asked to stop taking medication to participate in the study;
• Pregnancy or lactation
• Blood donation within eight weeks of the start of the study.
• History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
• Unable to safely discontinue or hold aspirin and other NSAID use
• MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
• Participation in other research studies involving inonizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers.
• Subject who has current, past, or anticipated exposure to radiation in the work place within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
• Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
• History of complicated alcohol withdrawal including history of delirium tremens; seizure, hospitalization for withdrawal.
• Alcohol intoxication at time of screening.
• A CIWA score ≥8 at intake or on scan day.
• Subjects who are, in the opinion of the study physician, unable to safely abstain from alcohol overnight prior to their study visits.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06518, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Kelly Cosgrove

CONTACT

2037376969; kelly.cosgrove@yale.edu

Marc Grasso, Ba

CONTACT

2037377074; marc.grasso@yale.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)