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

NCT05885594 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 851462
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use; Healthy Volunteer

Outcome Measures

Primary Outcomes (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.

  2 hours

Secondary Outcomes (2)

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

  1 hour

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

  1 hour

Other Outcomes (1)

• [18F]NOS uptake (distribution volume) in the brain and other organs in body pre and post treatment with Ibudilast

  2 hours

Study Arms (2)

AUD-Alcohol Use Disorder

OTHER

60 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.

Drug: [18F]NOS

HV-Healthy Volunteer

OTHER

30 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.

Drug: [18F]NOS

Interventions

[18F]NOS DRUG

\[18F\]-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.

Also known as: FNOS

AUD-Alcohol Use Disorder; HV-Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

Fluorine-18

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Jacob Dubroff, MD, PhD

  Perelman School of Medicine, Dept. of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 2, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)