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MinorEligibility criteria expanded, about 18 words
Study description revised
Minor10 versionsRe-verified since Mar 25, 2025, no change to tracked fieldsv32-v41
MinorStart date changed from estimate of Mar 27, 2025 to Mar 20, 2025v31
MinorStart date: Mar 26, 2025 to Mar 27, 2025v30
MinorStart date: Mar 25, 2025 to Mar 26, 2025v29
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MinorStart date: Mar 24, 2025 to Mar 25, 2025v28
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MinorStart date: Mar 11, 2025 to Mar 12, 2025v19
MinorStart date: Mar 10, 2025 to Mar 11, 2025v18
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MinorStart date: Mar 6, 2025 to Mar 9, 2025v16
MinorStart date: Mar 5, 2025 to Mar 6, 2025v15
MinorStart date: Mar 4, 2025 to Mar 5, 2025v14
MinorStart date: Mar 3, 2025 to Mar 4, 2025v13
MinorStart date: Mar 2, 2025 to Mar 3, 2025v12
MinorStart date: Feb 27, 2025 to Mar 2, 2025v11
MinorStart date: Feb 26, 2025 to Feb 27, 2025v10
MinorStart date: Feb 25, 2025 to Feb 26, 2025v9
MinorStart date: Feb 24, 2025 to Feb 25, 2025v8
MinorStart date: Feb 23, 2025 to Feb 24, 2025v7
MinorStart date: Feb 20, 2025 to Feb 23, 2025v6
NotableTrial status: Not Yet Recruiting to Recruiting
Site details revised
v5
MinorTrial status: Recruiting to Not Yet Recruiting
Site details revised
v4
MinorSite contact updatedv3
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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....