ClinicalTrials.gg
RecruitingNCT07488819Updated Jun 11, 2026

Imaging Phosphodiesterase 4B (PDE4B) in People With Psychiatric Disorders With Positron Emission Tomography (PET) and the Radiotracer [18F]PF974

An observational study in Post-Traumatic Stress Disorder, PTSD and Alcohol Use Disorder (AUD), sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Yale University · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer [18F]PF974

02

Conditions studied

  • Post-Traumatic Stress Disorder, PTSD
  • Alcohol Use Disorder (AUD)
03

In context

Combat Disorders

200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.

This study's planned enrollment of 160 is above the median of 140 across 26 observational studies indexed under Combat Disorders.

Browse Combat Disorders studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to give voluntary written .
  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, , serum/urine biochemistry, hematology, and serology tests.
  5. Participants with AUD will have a current diagnosis of AUD according to 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

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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • PTSD

    Subjects with Post-Traumatic Stress Disorder

    Drug: PF974

  • AUD

    Subjects with Alcohol Use Disorder

    Drug: PF974

  • Healthy Controls (HC)

    Healthy control subjects without AUD or PTSD/Trauma

    Drug: PF974

  • Trauma Controls (TC)

    Trauma Exposed Healthy Controls without AUD or PTSD

    Drug: PF974

Interventions

  • DrugPF974

    PF974 Radiotracer.

06

What researchers measure

Primary outcomes

  1. Regional [18F]PF974 volume of distribution (VT)

    proportional to the levels of PDE4B available for radiotracer binding

    Time frame: Once at baseline

Secondary outcomes

  1. Secondary Region Of Interest (ROI) Binding of [18F]PF974

    Ventromedial and dorsolateral prefrontal cortex; the insula, occipital, parietal, and temporal cortices; amygdala, and thalamus.

    Time frame: Once at Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07488819
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Mar 23, 2026
Start date
Jul 7, 2025
Primary completion
Mar 1, 2031 (estimated)
Completion
Mar 1, 2032 (estimated)
Last update
Jun 11, 2026

Study contacts

Marc V Grasso
Contact
marc.grasso@yale.edu
2037377074
Kelly Cosgrove, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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