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NCT07027839 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Alcohol Use Disorder, sponsored by National Institute of Mental Health (NIMH).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT07027839 is a Phase 1 study of Alcohol Use Disorder that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 30 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07027839, a Phase 1 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

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 Studied

Interventions

  • DRUG Intravenous Ethanol
  • DRUG 18F-PF-06445974

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-12-11
Est. Completion 2029-02-22
Phase Phase 1

What the Registry Record Tells You About NCT07027839

The ClinicalTrials.gov registry entry for NCT07027839 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Intravenous Ethanol is the first listed.

NCT07027839 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT07027839 about?

NCT07027839 is a clinical study titled "Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)". 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. Th...

What is the current status of trial NCT07027839?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-12-11. Estimated completion is 2029-02-22.

What conditions does trial NCT07027839 study?

This clinical trial studies the following conditions: Alcohol Use Disorder.

What interventions are being tested in trial NCT07027839?

The interventions under investigation include: Intravenous Ethanol (DRUG), 18F-PF-06445974 (DRUG).

Who is sponsoring clinical trial NCT07027839?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07027839 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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