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

• Status: Not yet recruiting
• Trial end date: 2027-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania

Criteria

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:

• Unwilling or unable to refrain from use, within 24 hours of MRI and PET procedures, medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs)

• 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