Alcohol Use DisorderPhase 1NCT06795581
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
A Phase 1 study testing 18F-PF-06445974 in people with Alcohol Use Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- 18F-PF-06445974
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 31 Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Willingness to complete the study including MRI tests.
- Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Participants must agree to adhere to the lifestyle considerations.
- Enrolled in protocol 14-AA-0181.
Who cannot join
- Clinically significant 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).
- Clinically significant abnormalities on EKG.
- Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
- Participants with a breath alcohol level (BAL) past 0.08.
- Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
- Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission.
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- HIV infection.
- Pregnancy.
- Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.
- Have an inability to lie flat and/or lie still on the camera bed for two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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....
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- 18F-PF-06445974
- Keywords
- PET Imaging, Alcohol Use Disorder (AUD), Phosphodiesterase-4B (PDE4B)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PF-06445974Drug
Injected IV followed by PET scanning
| Study group | Role | What they receive |
|---|---|---|
| One-arm | Other | All subjects will receive the same tests. Receives: Drug: 18F-PF-06445974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure distribution volume
Target quantification
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start20 Mar 2025
- Primary completion11 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795581
- Sponsor's protocol ID
- 10002210
- Other IDs
- 002210-M
- Status last verified
- 15 Oct 2026
- First submitted
- 25 Jan 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be submitted to ClinicalTrials.gov@@@@@@