Imaging brain protein levels in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.