Clinical Trial

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

Recruiting Phase 1
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Summary
Background: 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) 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 also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....
Protocol Amendment History 39 amendments
This ClinicalTrials.gov record has been amended 39 times since 2025-01-25; most recent amendment 2026-07-03.
Status change: Not Yet Recruiting → Recruiting 2025-02-13
Status change: Recruiting → Not Yet Recruiting 2025-02-11
Trial Details
NCT Number NCT06795581
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions Alcohol Use Disorder
Enrollment 30 participants
Start Date 2025-03-20
Primary Completion 2028-12-11 (estimated)
Study Completion 2029-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-07