A Phase 1 interventional study of 18F-PF-06445974 and Oxazepam in Alcohol Use Disorder, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Institute of Mental Health (NIMH) · Phase 1, Interventional, and Diagnostic
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/CT) 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 have a single dose of oxazepam (30 mg) administered prior to the first PET/CT scan.
Participants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....
Study Description:
AUD participants will be referred from protocol 14-AA-0181, which includes a four-week hospitalization at NIH for alcohol withdrawal. Using the PET radioligand [18F]PF974 to measure the density of PDE4B, AUD participants will be scanned twice: 1) within one week of admission, and 2) after 3-4 weeks of alcohol withdrawal.
Objectives:
Primary Objective #1: To determine whether PDE4B radioligand binding is decreased in AUD participants during acute withdrawal compared to healthy volunteers matched as a group for age and sex.
Primary Objective #2: To determine whether PDE4B radioligand binding increases in individuals on the second scan compared to the first.
Secondary Objective: No exploratory correlations are hypothesized for this novel imaging of PDE4B. However, we may later perform correlations with any of the clinical parameters or biological biomarkers obtained in the 14- AA-0181. Note that Dr. Diazgranados is an AI of this PET protocol, and Dr. Innis will become an AI of the parent protocol.
Endpoints:
Primary endpoint: For both objectives, the primary endpoint is PET measurement of PDE4B binding (VT) in all regions of the brain.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 30 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 19, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 18-70 years
EXCLUSION CRITERIA:
abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will receive the same tests.
Drug: 18F-PF-06445974 · Drug: Oxazepam
Injected IV followed by PET scanning
Oral administration of oxazepam
To measure distribution volume
Target quantification
Time frame: 36 months
Plan to share: Yes — The results will be submitted to ClinicalTrials.gov@@@@@@
Supporting information: Study protocol
Time frame: 18 months after closure of protocol@@@@@@
Access criteria: BTRIS
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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