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Taking people in United StatesPhase 1

PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder

Key facts

Who runs it
National Institute of Mental Health (NIMH)
Where
Bethesda, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 1
People taking part
30 people, planned
Started
20 Mar 2025
Expected to end
31 Jan 2029
Type of study
Interventional
Treatments tested
  • 18F-PF-06445974
  • Oxazepam
Record updated
27 October 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who cannot take part

  • Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission
  • Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits
  • Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy)
  • HIV infection
  • Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye
  • Clinically significant abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)
  • Clinically significant abnormalities on EKG
  • Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk
  • Participants with a breath alcohol level (BAL) past 0.08
  • Pregnancy
  • Have an inability to lie flat and/or lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit

Other criteria

  • INCLUSION CRITERIA:; Age 18-70 years; Willingness to complete the study including MRI tests; Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document; Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists; Participants must agree to adhere to the lifestyle considerations; Enrolled in protocol 14-AA-0181

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in United States

  • National Institutes of Health Clinical CenterBethesda, United StatesContact: NIH Clinical Center Office of Patient Recruitment (OPR)Taking people

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD.

Objective:

To find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks.

Eligibility:

Adults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181.

Design:

Participants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study.

Within the first week, participants will have a positron emission tomography (PET/CT) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine.

Participants will have a second PET scan toward the end of their stay in the clinic.

Participants may have a single dose of oxazepam (30 mg) administered prior to the first PET/CT scan.

Participants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....

The group in the trial

  • One-armOther group

    All subjects will receive the same tests.

    Treatment: 18F-PF-06445974 and Oxazepam

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT06795581, who can take part
Record updated
27 October 2026