RECRUITING

PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder

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Conditions

Alcohol Use DisorderPET ImagingAlcohol Use Disorder (AUD)Phosphodiesterase-4B (PDE4B)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder

Quick Facts

Study Start:2025-03-20
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06795581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-70 years
  2. 2. Willingness to complete the study including MRI tests.
  3. 3. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
  4. 4. 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.
  5. 5. Participants must agree to adhere to the lifestyle considerations.
  6. 6. Enrolled in protocol 14-AA-0181
  1. 1. Clinically significant abnormalities on EKG.
  2. 2. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
  3. 3. Participants with a breath alcohol level (BAL) past 0.08.
  4. 4. 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).
  5. 5. Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission.
  6. 6. HIV infection.
  7. 7. Pregnancy.
  8. 8. 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.
  9. 9. 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.
  10. 10. 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.
  11. 11. Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

Contacts and Locations

Study Contact

Tara N Turon, C.R.N.P.
CONTACT
(301) 827-6599
tara.turon@nih.gov
Robert B Innis, M.D.
CONTACT
(301) 594-1368
robert.innis@nih.gov

Principal Investigator

Robert B Innis, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Robert B Innis, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-20
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2025-03-20
Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

  • PET Imaging
  • Alcohol Use Disorder (AUD)
  • Phosphodiesterase-4B (PDE4B)

Additional Relevant MeSH Terms

  • Alcohol Use Disorder