Imaging brain protein levels in people with alcohol use disorder
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
This study is testing if the levels of a brain protein called PDE4B change in people with alcohol use disorder during withdrawal and after they stop drinking for a while.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06795581 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the levels of the protein phosphodiesterase-4B (PDE4B) in the brains of individuals with alcohol use disorder (AUD) during withdrawal. Participants will undergo a four-week hospitalization for alcohol withdrawal, during which they will receive positron emission tomography (PET) scans to measure PDE4B levels at two time points: within the first week of admission and after 3-4 weeks of abstinence. The study seeks to determine if PDE4B levels are lower during acute withdrawal compared to healthy volunteers and if these levels increase after a period of abstinence.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 years who are experiencing alcohol withdrawal and are enrolled in protocol 14-AA-0181.
Not a fit: Patients with clinically significant abnormalities on laboratory tests or those posing a serious risk of self-harm may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options for individuals suffering from alcohol use disorder.
How similar studies have performed: While this approach is novel in the context of alcohol use disorder, similar imaging studies have shown promise in understanding other neurobiological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Robert B Innis, M.D. — National Institute of Mental Health (NIMH)
- Study coordinator: Tara N Turon, C.R.N.P.
- Email: tara.turon@nih.gov
- Phone: (301) 827-6599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.