Scientists to scan brains of people with PTSD and alcohol addiction
NCT ID NCT07488819
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses a special PET scan tracer to measure a brain protein called PDE4B in people with PTSD or alcohol use disorder. Researchers want to see if levels of this protein differ from healthy individuals. The study involves 160 adults aged 18 to 70 and does not offer treatment, only observation.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Up to 40 AUD subjects may be enrolled. Up to 40 PTSD subjects may be enrolled. Up to 40 HC subjects may be enrolled. Up to 40 TC subjects may be enrolled.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing and able to give voluntary written informed consent. 2. 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. 3. Men or women, aged 18 to 70, at screening. 4. In good general health as evidenced by medical history, physical examination, electrocardiogram, serum/urine biochemistry, hematology, and serology tests. 5. Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (SCID-5) ascertained diagnosis, confirmed by the Principal Investigators). 6. 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. 7. 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. 8. Healthy control 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. Subjects who have have a DSM-5 criteria traumatic event with no PTSD diagnosis may also be considered healthy controls for Aim 1. 9. Renal function and hepatic function will be within normal limits (for age and sex) on the laboratory tests. Elevated liver enzymes for individuals with alcohol use disorder are permitted at the discretion of the study physician. Exclusion Criteria: 1. 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). 2. 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. 3. Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\*) and past or current psychotic symptoms. 4. 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; No subject will be asked to stop taking medication to participate in the study. Participants who are regularly taking P-gp and BCRP inhibitors will be excluded. 5. Pregnancy or lactation. 6. Blood donation within eight weeks of the start of the study. 7. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto). 8. Unable to safely discontinue or hold aspirin and other NSAID use. 9. 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). 10. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers. 11. 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. 12. Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol. 13. History of complicated alcohol withdrawal including history of delirium tremens; seizure, hospitalization for withdrawal. 14. A CIWA score ≥8 at intake or on scan day. 15. Subjects who are, in the opinion of the study physician, unable to safely abstain from alcohol overnight prior to their study visits. 16. Subjects with a significant history of repeated alcohol withdrawal, defined as 4 or more medicated detoxifications in the previous 5 years
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale University
RECRUITINGNew Haven, Connecticut, 06510, United States
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