PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
A legfontosabb adatok
- Ki végzi
- National Institute of Mental Health (NIMH)
- Hol
- Bethesda (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 1. fázis
- Résztvevők
- 30 fő, tervezett
- Kezdés
- 2025. márc. 20.
- Várható befejezés
- 2029. jan. 31.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- 18F-PF-06445974
- Oxazepam
- A regiszteradat frissítve
- 2026. október 27.
Ki vehet részt
- Életkor
- 18 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 12 feltétel megnézéseKevesebb
Ki nem vehet részt
- Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission
- 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
- 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)
- HIV infection
- 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
- 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
- Pregnancy
- 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
Egyéb feltételek
- INCLUSION CRITERIA:; 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 70 év között vagy?
Helyszínek itt: Egyesült Államok
- National Institutes of Health Clinical CenterBethesda, Egyesült ÁllamokContact: NIH Clinical Center Office of Patient Recruitment (OPR)Résztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
Background:
A teljes eredeti leírásKevesebb
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....
A vizsgálat csoportja
- One-armEgyéb csoport
All subjects will receive the same tests.
Kezelés: 18F-PF-06445974 és Oxazepam
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Illeszkedési kérdések
- Forrás: NCT06795581: ki vehet részt
- A regiszteradat frissítve
- 2026. október 27.