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Alcohol Use DisorderEarly Phase 1AUDNCT05885594

Imaging Inflammation With Alcohol Use Disorder: an [18F]NOS Study

A Early Phase 1 study testing [18F]NOS in people with Alcohol Use Disorder, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Study to enroll up to 90 individuals, those with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30). PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer [18F]NOS. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
[18F]NOS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
8 Aug 2023to 15 Mar 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years to 65 years old (inclusive)
  • Willingness to provide signed informed consent and commit to completing the procedures in the study
  • 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.
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  • 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)
  • 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.
  • AUDIT score < 6
  • Drinks alcohol 15 standard drinks or less per month (by self-report).

Who cannot join

  • 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
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  • 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
  • Current DSM-5 diagnosis of Alcohol use disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Imaging Inflammation in Individuals With Alcohol Use Disorder: an [18F]NOS Study

Study to enroll up to 90 individuals, those with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30).

PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer [18F]NOS.

All participants will have one [18F]NOS positron emission tomography/ computed tomography (PET/CT) scan performed.

Read the detailed description

The Investigators plan to enroll up to 90 individuals in this study, which will enroll individuals with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30).

PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer [18F]NOS. All participants will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed, unless this has been performed as part of another study. AUD participants enrolled in a companion treatment study #851593 "A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder" will be asked to undergo a second [18F]NOS PET scan after the initiation of the study treatment.

For each PET/CT scan, patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of [18F]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of [18F]NOS. Data will be collected to evaluate uptake of [18F]NOS in the brain and other organs (e.g., lungs, heart, and liver), and measurements will be compared between groups.

Each participant will undergo a 90 minute brain MRI to measure brain inflammatory markers using GluCEST and spectroscopic imaging, unless this has been performed as part of another study and deemed acceptable by an investigator. On the PET day, a blood sample will be collected to measure established peripheral inflammatory biomarkers to be correlated with [18F]NOS uptake. AUD participants who are enrolled in the companion treatment study will be asked to undergo a second brain MRI, PET/CT scan, and blood draw for inflammatory markers after the initiation of treatment.

Being tested
[18F]NOS
Keywords
Alcohol Use, Healthy Volunteer
Medical subject headings
Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]NOSDrug

    Also called FNOS

    [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine, also known as [18F]NOS, is a positron emitting radiopharmaceutical that has been studied in animals and humans which permits the visualization and measurement by positron emission tomography (PET/CT) imaging of in vivo iNOS expression as a marker of inflammation.

Study groups in NCT05885594
Study groupRoleWhat they receive
AUD-Alcohol Use DisorderOther60 adult men and women who have alcohol use disorder will undergo up to 2 PET/CT scans each approximately 60 minutes of dynamic scanning starting at the time of injection of [18F]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of [18F]NOS.
Receives: Drug: [18F]NOS
HV-Healthy VolunteerOther30 adult men and women between the ages of 18-65 who do not have alcohol use disorder and are a healthy volunteer will be enrolled in this study.
Receives: Drug: [18F]NOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [18F]NOS uptake (distribution volume) in the brain and other organs in body

    The primary outcome measure to be analyzed is a comparisons of AUD subjects and healthy control subjects in the amount of [18F]NOS uptake (distribution volume) in brain and heart.

    Measured: 2 hours

Secondary outcomes (2)

  1. Amount of c-reactive protein (mg/dl) in blood

    The secondary outcome measure is the comparison of AUD subjects and healthy control subjects in the amount of c-reactive protein in mg/dl, and its association with [18F]NOS uptake (distribution volume) in brain and other organs in body.

    Measured: 1 hour

  2. Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain

    The third outcome measure to be analyzed is the comparison of AUD subjects and healthy control subjects in brain Glutamate levels (in mM), and its association with [18F]NOS uptake (distribution volume) in brain.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start8 Aug 2023
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885594
Sponsor's protocol ID
851462
Acronym
AUD
Status last verified
Nov 2025
First submitted
8 May 2023
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]NOS in people with Alcohol Use Disorder, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[18F]NOS uptake (distribution volume) in the brain and other organs in body (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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