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

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. According to ClinicalTrials.gov, the official US trial registry.

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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....

Primary Outcome

Target quantification

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
National Institute of Mental Health (NIMH)

343 total trials

What NCT06795581 shows while recruiting

NCT06795581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (91% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Alcohol Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06795581's enrollment target sits among peer trials

30 151st of 184 higher than 26 of 184 other Alcohol Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06795581

Source: ClinicalTrials.gov NCT06795581, the US trial registry maintained by the National Library of Medicine. NCT06795581 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.