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NCT06795581 · ClinicalTrials.gov registry record · Phase 1

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

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

NCT06795581 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

NCT06795581, 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: 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 Studied

Alcohol Use Disorder

Interventions

  • DRUG 18F-PF-06445974

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-03-20
Est. Completion 2029-01-31
Phase Phase 1

Sponsor

National Institute of Mental Health (NIMH)

343 total trials

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What the Registry Record Tells You About NCT06795581

The ClinicalTrials.gov registry entry for NCT06795581 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 1 intervention - of which 18F-PF-06445974 is the first listed.

NCT06795581 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06795581 about?

NCT06795581 is a clinical study titled "PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder". 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...

What is the current status of trial NCT06795581?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-03-20. Estimated completion is 2029-01-31.

What conditions does trial NCT06795581 study?

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

What interventions are being tested in trial NCT06795581?

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

Who is sponsoring clinical trial NCT06795581?

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

Where is trial NCT06795581 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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