Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06795581

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

Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-24

30

Participants Needed

1

Research Sites

201 weeks

Total Duration

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AI-Summary

What this Trial Is About

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....

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years
  • Willingness to complete the study including MRI tests
  • Ability to understand and agree to all required tests and sign informed consent
  • Radial artery pulse checked with adequate ulnar collateral flow and no metal/foreign objects in wrists
  • Agreement to follow lifestyle considerations
  • Enrollment in protocol 14-AA-0181
Not Eligible

You will not qualify if you...

  • Significant lab abnormalities beyond those expected during alcohol withdrawal (including CBC and acute care panel)
  • Clinically significant EKG abnormalities
  • Serious suicidal or homicidal risk as judged by investigators
  • Breath alcohol level above 0.08
  • Unstable medical conditions making participation unsafe (e.g., active infection, untreated malignancy)
  • Use of antidepressants or antipsychotics within the past week or during hospital admission
  • HIV infection
  • Pregnancy
  • Recent research-related radiation exposure exceeding allowable limits
  • Inability to lie flat and still for two hours, including claustrophobia or excessive weight
  • Inability to have MRI due to implants, metal fragments, or other contraindications
  • Being NIMH staff or NIH employee subordinate, relative, or co-worker of investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Tara N Turon, C.R.N.P.

CONTACT

R

Robert B Innis, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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