NCT06795581 PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
| NCT ID | NCT06795581 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2028-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-20 with a primary completion date of 2028-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
* INCLUSION CRITERIA: 1. Age 18-70 years 2. Willingness to complete the study including MRI tests. 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. 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. Participants must agree to adhere to the lifestyle considerations. 6. Enrolled in protocol 14-AA-0181 EXCLUSION CRITERIA: 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). 1. Clinically significant abnormalities on EKG. 2. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. 3. Participants with a breath alcohol level (BAL) past 0.08. 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. Participants who have taken antidepressants or antipsychotic medications in the week prior or during their hospital admission. 6. HIV infection. 7. Pregnancy. 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. 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. 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. Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
Contact & Investigator
Robert B Innis, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT06795581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06795581 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06795581 currently recruiting?
Yes, NCT06795581 is actively recruiting participants. Contact the research team at tara.turon@nih.gov for enrollment information.
Where is the NCT06795581 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06795581 clinical trial?
NCT06795581 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Robert B Innis, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 30 participants.