New scan reveals hidden inflammation in heavy drinkers
NCT ID NCT05885594
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study is testing a new PET scan tracer called [18F]NOS to see if it can detect inflammation in the brain and body of people with alcohol use disorder (AUD). Researchers will compare up to 60 people with AUD and up to 30 healthy volunteers. Each person gets one PET/CT scan. The goal is to learn more about how inflammation relates to AUD, not to treat the condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]NOS (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could help researchers understand how inflammation relates to alcohol use disorder, potentially pointing toward new treatment targets.
- What could go wrong
- This is a very early, small study (only 4 participants planned) that is not testing a treatment. The tracer is investigational and may not show clear differences between groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
4 people
The number who actually took part.
- Started
-
Aug 2023
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for both study groups (AUD and HV) * Age 18 years to 65 years old (inclusive) * Willingness to provide signed informed consent and commit to completing the procedures in the study Inclusion criteria for the AUD group: * Meets DSM-5 criteria for AUD * Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report) * Minimum 1 year history of heavy drinking (self-report). * Must have had last drink within 1 week of the first PET visit. * Alcohol specified as the preferred drug (self-report) * Participants must agree to not consume alcohol beverages for 12 hours prior to laboratory sessions (self-report with 0 breath alcohol level) Inclusion criteria for the AUD treatment group: * Enrolled in the clinical trial titled "A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder" and eliglible to be randomized into the study to receive study medication. Inclusion criteria for the HV group: * AUDIT score \< 6 * Drinks alcohol 15 standard drinks or less per month (by self-report). Exclusion Criteria for both study groups: * Females who have a positive urine pregnancy test or are breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening, MRI, and at the PET/CT scan visits * Current untreated and unstable diagnosis of substance use disorder that could interfere with study participation or make it hazardous for the subject to participate (except for nicotine or cannabis use disorder, and alcohol use disorder in the alcohol group) * Positive urine drug screen for opiates, methamphetamine or cocaine at screening or study visit (may be repeated once and if result is negative on repeat it is not exclusionary) * Individuals who are HIV positive, as the human immunodeficiency virus affects neurocognitive function, even in otherwise asymptomatic individuals, which can confound the results of PET and MRI testing * Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder, psychotic major depression, panic disorder, or imminent suicide or violence risk) that could compromise participant safety or successful participation in the study * Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report and judged by a physician investigator to be potentially confounding * Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI (self-report, medical history) * Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI and or PET scanner (self-report checklist) * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician * Any current or past medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study * Judged by the principal investigator or his designee to be an unsuitable candidate for study participation Exclusion criteria for the HV group: * Current DSM-5 diagnosis of Alcohol use disorder
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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