Alcohol Use Disorder study: 18F-PF-06445974 vs Oxazepam
Official title PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06795581
What this study is testing
What is 18F-PF-06445974?
an investigational radioactive tracer being studied to measure PDE4B levels in people with alcohol use disorder
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a brain protein called PDE4B is lower while people are withdrawing from alcohol and if it rises after they stop drinking for a few weeks.
- Who it's for
- Adults 18‑70 years old who have alcohol use disorder and are part of protocol 14‑AA‑0181.
- What's involved
- Participants will stay in a clinic for 3‑4 weeks, have a PET scan with a radioactive tracer that highlights PDE4B, and may also get an MRI. A small tube will be inserted into a vein to give the tracer.
- Time commitment
- The study lasts 3‑4 weeks, with two PET scans and possibly an MRI during the stay.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1. 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...
- Participants must agree to adhere to the lifestyle considerations.
You likely can't join if
- Clinically significant abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal.
- 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...
- Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission.
See the full eligibility criteria
- 1. 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.
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.