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

ConditionsAlcohol Use Disorder Post Traumatic Stress Disorder

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-70

SponsorYale University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary)

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;

Trial 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.

Trial design

Design model

Ecologic or community

Time perspective

Retrospective

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 5 treatment groups

Group A: PTSD1 intervention

Group B: AUD1 intervention

Group C: PTSD & AUD1 intervention

Group D: HC1 intervention

Group E: TC1 intervention

Trial outcomes

Primary outcomes

HDAC6 expression in people with Post-Traumatic Stress Disorder

Time frame

Baseline

HDAC6 expression in people with Alcohol use Disorder

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

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