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

Phase 1
Recruiting
Conditions
Alcohol Use Disorder
Registration Number
NCT05885594
Lead Sponsor
University of Pennsylvania
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
90
Inclusion Criteria

Inclusion Criteria for both study groups (AUD and HV)<br><br> - Age 18 years to 65 years old (inclusive)<br><br> - Willingness to provide signed informed consent and commit to completing the<br> procedures in the study<br><br>Inclusion criteria for the AUD group:<br><br> - Meets DSM-5 criteria for AUD<br><br> - Average weekly ethanol consumption of at least 15 standard drinks over the past<br> month prior to consent (self-report)<br><br> - Minimum 1 year history of heavy drinking (self-report).<br><br> - Must have had last drink within 1 week of the first PET visit.<br><br> - Alcohol specified as the preferred drug (self-report)<br><br> - Participants must agree to not consume alcohol beverages for 12 hours prior to<br> laboratory sessions (self-report with 0 breath alcohol level)<br><br>Inclusion criteria for the AUD treatment group:<br><br> - Enrolled in the clinical trial titled A Randomized, Double-blind Placebo-Controlled<br> Study of Ibudilast for Treating Alcohol Use Disorder and eliglible to be randomized<br> into the study to receive study medication.<br><br>Inclusion criteria for the HV group:<br><br> - AUDIT score < 6<br><br> - Drinks alcohol 15 standard drinks or less per month (by self-report).<br><br>Exclusion Criteria for both study groups:<br><br> - Unwilling or unable to refrain from use, within 24 hours of MRI and PET procedures,<br> medication that may affect study results (e.g., analgesics containing narcotics,<br> antibiotics, anti-inflammatory drugs)<br><br> - Females who have a positive urine pregnancy test or are breast feeding at the time<br> of screening will not be eligible for this study; a urine pregnancy test will be<br> performed in women of child-bearing potential at screening, MRI, and at the PET/CT<br> scan visits<br><br> - Current untreated and unstable diagnosis of substance use disorder that could<br> interfere with study participation or make it hazardous for the subject to<br> participate (except for nicotine or cannabis use disorder, and alcohol use disorder<br> in the alcohol group)<br><br> - Positive urine drug screen for opiates, methamphetamine or cocaine at screening or<br> study visit (may be repeated once and if result is negative on repeat it is not<br> exclusionary)<br><br> - Individuals who are HIV positive, as the human immunodeficiency virus affects<br> neurocognitive function, even in otherwise asymptomatic individuals, which can<br> confound the results of PET and MRI testing<br><br> - Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder,<br> psychotic major depression, panic disorder, or imminent suicide or violence risk)<br> that could compromise participant safety or successful participation in the study<br><br> - Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical<br> record review or self-report and judged by a physician investigator to be<br> potentially confounding<br><br> - Head trauma with loss of consciousness for more than 30 minutes or associated with<br> skull fracture or inter-cranial bleeding or abnormal MRI (self-report, medical<br> history)<br><br> - Presence of ferromagnetic objects in the body that are contraindicated for MRI of<br> the head, fear of enclosed spaces, or other standard contraindication to MRI and or<br> PET scanner (self-report checklist)<br><br> - Inability to tolerate imaging procedures in the opinion of an investigator or<br> treating physician<br><br> - Any current or past medical condition, illness, or disorder as assessed by medical<br> record review and/or self-reported that is considered by a physician investigator to<br> be a condition that could compromise participant safety or successful participation<br> in the study<br><br> - Judged by the principal investigator or his designee to be an unsuitable candidate<br> for study participation<br><br>Exclusion criteria for the HV group:<br><br> - Current DSM-5 diagnosis of Alcohol use disorder

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
[18F]NOS uptake (distribution volume) in the brain and other organs in body
Secondary Outcome Measures
NameTimeMethod
Amount of c-reactive protein (mg/dl) in blood;Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain
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