PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNational Institute of Mental Health (NIMH)
About this trial
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....
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- 18F-PF-06445974
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov