Actively Recruiting

Phase 1
Age: 21Years - 70Years
All Genders
NCT07027839

Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-13

30

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Phosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and/or amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD). Objective: To learn if alcohol increases PDE4B activity in the brain. Eligibility: Healthy people aged 21 to 70 years who drink socially but do not have AUD. They must be enrolled in protocol 14-AA-0181"NIAAA Natural History Protocol". Design: Participants will have up to 4 clinic visits with up to 3 imaging scans of the brain; these will include 1 or 2 positron emission tomography (PET) scans and 1 magnetic resonance imaging (MRI) scan. The first PET scan will be a baseline. Participants will receive a radioactive tracer through a tube inserted into a vein. A second tube will be inserted so that blood can be drawn during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. This visit will take about 6 hours. For the next PET scan, participants will receive alcohol (ethanol) through a tube in a vein until they have a blood alcohol concentration that is equal to the legal driving limit. This is the same as 4 or 5 drinks for most people. After the scan, participants must remain at the clinic for a few hours until their blood alcohol drops. This visit will take 14 to 16 hours. The MRI scan of the brain will take up to 2 hours in a separate clinic visit.

CONDITIONS

Official Title

Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be enrolled in protocol 14-AA-0181, NIAAA Natural History Protocol
  • Age between 21 and 70 years
  • Willing to complete the study including MRI tests
  • In good general health based on medical history and physical exam
  • Have adequate ulnar collateral blood flow confirmed by radial artery pulse check
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • History of alcohol use disorder or substance use disorder
  • Current non-drinker or no history of drinking 5 or more drinks on one occasion
  • History of alcohol-induced flushing reactions after 1 or 2 drinks
  • Significant abnormalities on EKG or lab tests including liver function
  • Use of antipsychotic or antidepressant medications within 2 weeks prior to first PET scan
  • Use of medications that interact with alcohol within 2 to 4 weeks prior to screening
  • HIV infection
  • Pregnancy or breastfeeding
  • Recent radiation exposure above allowable limits
  • Inability to lie flat or still for two hours due to claustrophobia, weight, or behavior
  • Unable to have MRI scan due to implanted metal devices or fragments

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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