Post-Traumatic Stress Disorder, PTSDNCT07488819
Imaging Phosphodiesterase 4B (PDE4B) in People With Psychiatric Disorders With Positron Emission Tomography (PET) and the Radiotracer [18F]PF974
An observational study of Post-Traumatic Stress Disorder, PTSD and Alcohol Use Disorder (AUD), run by Yale University at 1 site in United States.
Trial summary
Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer [18F]PF974 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder, PTSD, Alcohol Use Disorder (AUD)
- What is being tested?
- PF974
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 1 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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, electrocardiogram, serum/urine biochemistry, hematology, and serology tests.
- 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).
- 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.
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- 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.
- 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.
- 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.
Who cannot join
- 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; 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.
- Pregnancy or lactation.
- Blood donation within eight weeks of the start of the study.
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- 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 ionizing 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.
- 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.
- Subjects with a significant history of repeated alcohol withdrawal, defined as 4 or more medicated detoxifications in the previous 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Marc Grasso, 2037377074, marc.grasso@yale.edu
About this study
Official title: Imaging PDE4B in People With Psychiatric Disorders With PET and the Radiotracer [18F]PF974
Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer [18F]PF974
- Being tested
- PF974
- Medical subject headings
- Combat Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF974Drug
PF974 Radiotracer.
| Study group | Role | What they receive |
|---|---|---|
| PTSD | Subjects with Post-Traumatic Stress Disorder Receives: Drug: PF974 | |
| AUD | Subjects with Alcohol Use Disorder Receives: Drug: PF974 | |
| Healthy Controls (HC) | Healthy control subjects without AUD or PTSD/Trauma Receives: Drug: PF974 | |
| Trauma Controls (TC) | Trauma Exposed Healthy Controls without AUD or PTSD Receives: Drug: PF974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional [18F]PF974 volume of distribution (VT)
proportional to the levels of PDE4B available for radiotracer binding
Measured: 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.
Measured: Once at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start7 Jul 2025
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder, PTSDStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Cosgrove, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488819
- Sponsor's protocol ID
- 2000040000
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging PDE4B in People With Psychiatric Disorders With PET and the Radiotracer [18F]PF974
- ClinicalTrials.gov ID
- NCT07488819
- Acronym / sponsor ID
- 2000040000
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer [18F]PF974
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PTSD | – | Drug: PF974Subjects with Post-Traumatic Stress Disorder |
| AUD | – | Drug: PF974Subjects with Alcohol Use Disorder |
| Healthy Controls (HC) | – | Drug: PF974Healthy control subjects without AUD or PTSD/Trauma |
| Trauma Controls (TC) | – | Drug: PF974Trauma Exposed Healthy Controls without AUD or PTSD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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, electrocardiogram, serum/urine biochemistry, hematology, and serology tests.
- 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).
Key exclusion criteria (16 listed)
- 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; 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.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF974PF974 Radiotracer. | Drug | AUD, Healthy Controls (HC), PTSD, Trauma Controls (TC) |
Primary outcome
Regional [18F]PF974 volume of distribution (VT)
Time frame: Once at baseline
proportional to the levels of PDE4B available for radiotracer binding
1 secondary outcome
Secondary Region Of Interest (ROI) Binding of [18F]PF974
Time frame: Once at Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Cosgrove, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder, PTSD and Alcohol Use Disorder (AUD), run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc V Grasso (2037377074, marc.grasso@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional [18F]PF974 volume of distribution (VT) (time frame: Once at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.