Evaluation of in Vivo Neuroinflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in HIV Positive and Negative Subjects With Opioid Use Disorder and Healthy Controls
The purpose of this research is to measure the extent of inflammation in the brain between different groups of participants using a radioactive tracer called \[18F\]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This study will see how the tracer is taken up in the brain using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting at approximately the time of injection of \[18F\]NOS. Participants are required to have a brain MRI performed within 1 year prior to study enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for this study they will be asked to undergo a research brain MRI after they have consented for this study.
∙ Cohort A (HIV+/OUD+):
• 18-65 years of age
• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
• OUD positive (+): Participants will meet DSM-5 criteria for lifetime OUD and will be on a stable dosage of OUD treatment for at least four weeks prior to the screening visit.
• HIV positive (+): Diagnosed with HIV-1 infection per medical record review. Requirements for study participation for HIV+ participants:
‣ On stable ART regimen (no changes to treatment within 4 weeks of the Screening visit)
⁃ Viral load of less than or equal to 200 cells/mm3 within 12 months of screening (per medical record review)
⁃ CD4+ count greater than 200 cells/mm3 within 12 months of screening (per medical record review)
∙ Cohort B (HIV-/OUD+):
• 18-65 years of age
• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
• OUD positive (+): Participants will meet DSM-5 criteria for lifetime OUD and will be on a stable dosage of OUD treatment for at least four weeks prior to the screening visit.
• HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.
∙ Cohort C (HIV+/OUD-):
• 18-65 years of age
• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
• OUD negative (-): During the past year, must not meet criteria for lifetime OUD (as per DSM-5) and cannot have used an opioid for any reason in the past 30 days prior to screening as evidenced by self-report, medical record review, and urine drug testing at screening.
• HIV positive (+): Diagnosed with HIV-1 infection per medical record review. Requirements for study participation for HIV+ participants:
‣ On stable ART regimen (no changes to treatment within 4 weeks of the Screening visit)
⁃ Viral load of less than or equal to 200 cells/mm3 within 12 months of screening (per medical record review)
⁃ CD4+ count greater than 200 cells/mm3 within 12 months of screening (per medical record review)
∙ Cohort D (HIV-/OUD-, Healthy Controls):
• 18-65 years of age
• Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
• OUD negative (-): Must not meet criteria for lifetime OUD (as per DSM-5) and cannot have used an opioid for any reason in the past 30 days prior to screening as evidenced by self-report, medical record review, and urine drug testing at screening.
• HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test at screening.