<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04401917</url>
  </required_header>
  <id_info>
    <org_study_id>842717</org_study_id>
    <nct_id>NCT04401917</nct_id>
  </id_info>
  <brief_title>Evaluation of Neuroinflammation FNOS PET/CT in HIV (+) and (-) Subjects With OUD and Healthy Controls</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to measure the extent of inflammation in the brain between&#xD;
      different groups of participants using a radioactive tracer called [18F]NOS. A radioactive&#xD;
      tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the&#xD;
      body. This study will see how the tracer is taken up in the brain using an imaging scan&#xD;
      called Positron Emission Tomography / Computed Tomography (PET/CT).&#xD;
&#xD;
      Participants will undergo approximately 60 minutes of dynamic scanning of the brain starting&#xD;
      at approximately the time of injection of [18F]NOS.&#xD;
&#xD;
      Participants are required to have a brain MRI performed within 1 year prior to study&#xD;
      enrollment, or if the subject has not had a brain MRI that is deemed acceptable for use for&#xD;
      this study they will be asked to undergo a research brain MRI after they have consented for&#xD;
      this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioids have direct effects on immune function and opioid receptors are expressed on immune&#xD;
      cells, including T cells, B cells, macrophages, and microglia (3, 4). There is abundant&#xD;
      evidence that opioids dysregulate CNS immune function (5-7). However, opioids' effects on&#xD;
      immune function are complex, with both pro-inflammatory and immune suppressive effects having&#xD;
      been reported (8, 9). Although the immunosuppressive effects of opioids can increase&#xD;
      susceptibility to infection (6, 7), individuals with Opioid Use Disorder (OUD) have also been&#xD;
      found to have higher levels of inflammation than healthy controls (HCs) (10, 11). Opioids&#xD;
      have also been shown to enhance the expression of inducible nitric oxide synthase (iNOS), a&#xD;
      marker of oxidative stress, effects that are reversed by NOS inhibitors and in iNOS knockout&#xD;
      mice (12, 13). Increased expression of iNOS may also be a marker of morphine-induced&#xD;
      microglial activation and long-term neurochemical changes in the brains of individuals with&#xD;
      OUD may be due to elevated cytokine and NO levels via iNOS expression (14).&#xD;
&#xD;
      OUD is frequently accompanied by syndemic comorbidities, such as HIV infection (15). HIV&#xD;
      infection itself is associated with neuroinflammation, even among patients receiving&#xD;
      antiretroviral therapy (ART) (16-18). Thus, HIV may exacerbate the inflammatory effects of&#xD;
      OUD (19). Indeed, morphine treatment alone decreases expression of iNOS by microglia (vs.&#xD;
      control), but morphine and HIV in combination substantially increase iNOS expression beyond&#xD;
      the effect of HIV alone (20). This study proposes to use [18F]NOS PET/CT imaging to evaluate&#xD;
      neuroinflammation in HIV-positive and HIV-negative subjects with OUD, HIV-positive subjects&#xD;
      without OUD, and HCs.&#xD;
&#xD;
      In dynamic PET/CT, kinetic analysis of the dynamic time-course of the radiotracer uptake is&#xD;
      used to help distinguish delivery of the radiotracer from retention. For quantitation of&#xD;
      dynamic studies, the time-course of uptake is most accurately determined when there is direct&#xD;
      information available about the time-course of the radiotracer in the blood. This information&#xD;
      is used to delineate the data obtained from PET imaging and can lead to better image-derived&#xD;
      variables for study. The gold standard for kinetic modeling relies on having the time-course&#xD;
      of the radiotracer in the arterial blood as an input to create an arterial input function&#xD;
      (AIF) (21). To obtain direct arterial blood measurements, an arterial catheter is commonly&#xD;
      placed in the radial artery of the wrist. Short-term arterial catheterization in healthy&#xD;
      research subjects was reported to be safe with a low incidence of complications in 1,132&#xD;
      radial artery catheterizations performed for the purpose of PET research protocols (1&#xD;
      instance of symptomatic thrombotic occlusion was documented and resolved without intervention&#xD;
      within weeks of the occurrence) by Everett et al (22).&#xD;
&#xD;
      Arterial catheterization is a laborious procedure requiring specialized training and often&#xD;
      discourages people from participating in clinical studies. There may be alternative methods&#xD;
      of creating an input function using venous blood sampling and/or image-derived input&#xD;
      functions utilizing more limited blood sampling. Generally, arterial tracer kinetics are&#xD;
      different from venous kinetics (23). It may be possible to substitute venous samples for&#xD;
      arterial samples when taken during a transient equilibrium phase. Because the time at which&#xD;
      this equilibrium is reached differs between tracers and often between species, it cannot be&#xD;
      generalized. Thus, there is a limited time window of variable length that must be assessed&#xD;
      individually for each new radiotracer by first sampling arterial blood to allow for&#xD;
      correlation of the time course information. In addition, almost all radiotracers used in&#xD;
      brain imaging produce variable amounts of radiometabolites. Imaging alone cannot distinguish&#xD;
      the parent compound from its radioactive metabolites and plasma radioactivity from that of&#xD;
      whole blood, and in most cases it is necessary to collect blood samples to correct for&#xD;
      metabolites when performing kinetic modeling of image data. One potential way to estimate&#xD;
      radiometabolite concentrations without arterial sampling is by using late venous blood&#xD;
      samples, when the metabolite concentration is maximal and arterio-venous equilibrium has been&#xD;
      reached. This approach must be validated for each new radiotracer as the relative&#xD;
      concentrations of radiometabolites in venous and arterial blood may differ significantly and,&#xD;
      therefore, venous samples do not accurately estimate arterial metabolite concentrations (21).&#xD;
      However, whole-body dynamic imaging scans may not require arterial blood as an input to&#xD;
      create an AIF, and consequently, venous blood can be used as an alternative to measure&#xD;
      metabolites when the arterial blood pool is within the imaging field of view. Venous blood&#xD;
      sampling is the preferred approach when working with some populations (e.g., IV drug users).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">December 7, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 7, 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan</measure>
    <time_frame>3 years</time_frame>
    <description>comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan. Comparing the whole brain [18F]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparing the patterns of [18F]NOS brain uptake in HIV+ vs. HIV- subjects using PET/Ct scna</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing the patterns of [18F]NOS brain uptake in HIV+ vs. HIV- using PET/CT scan. Comparing the whole brain [18F]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status.</measure>
    <time_frame>3 years</time_frame>
    <description>compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare patterns of [18F]NOS brain uptake in regions implicated in HIV and OUD</measure>
    <time_frame>3 years</time_frame>
    <description>The magnitude of inducement of NOS due to OUD or HIV as measured in uptake of [18F]NOS will be estimated as the absolute difference in SUV or VT values from the corresponding left and right brain regions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing peripheral blood inflammatory biomarkers as a function of both the main and interactive effects of OUD and HIV status</measure>
    <time_frame>3 years</time_frame>
    <description>using the peripheral blood inflammatory biomarkers collected during the PET/CT scan and comparing this biomarker as a function of both the main and interactive effects of OUD and HIV status.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>HIV Infections</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HIV positive (HIV+) subjects with Opioid Use Disorder (OUD): HIV+/OUD+</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV negative (HIV-) subjects with OUD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HIV negative (HIV-) subjects with OUD: HIV-/OUD+</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV Positive (HIV+) subjects with OUD negative</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HIV+ subjects who may have been opioid-exposed but do not have current or past OUD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>HIV-, OUD- healthy controls who have been opioid-exposed but do not have current or past OUD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]NOS</intervention_name>
    <description>Participants will undergo approximately 60 minutes of dynamic whole-body scanning, including the brain, starting at approximately 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.</description>
    <arm_group_label>HIV Positive (HIV+) subjects with OUD negative</arm_group_label>
    <arm_group_label>HIV negative (HIV-) subjects with OUD</arm_group_label>
    <arm_group_label>HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)</arm_group_label>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <other_name>[18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-60 years of age&#xD;
&#xD;
          2. Informed of the investigational nature of this study and able to provide written&#xD;
             informed consent and participate in this study in accordance with institutional and&#xD;
             federal guidelines prior to study-specific procedures.&#xD;
&#xD;
          3. Opioid Use Disorder (OUD) status will be defined as the following (to determine which&#xD;
             cohort to be enrolled in):&#xD;
&#xD;
             OUD positive (+): Participants will meet DSM-5 criteria for current OUD and will be on&#xD;
             a stable dosage of OUD treatment for at least four weeks prior to the screening visit.&#xD;
&#xD;
             OUD negative (-): Must have never met DSM-5 criteria for OUD and not used an opioid&#xD;
             for any reason in the 30 days prior to screening by self-report, medical record&#xD;
             review, and urine drug testing at screening.&#xD;
&#xD;
          4. HIV status will be defined as the following (to determine which cohort subjects will&#xD;
             be enrolled in):&#xD;
&#xD;
             HIV positive (+): Diagnosed with HIV-1 infection per medical record review.&#xD;
             Requirements for study participation for HIV+ participants:&#xD;
&#xD;
               -  On stable ART regimen (no changes to treatment within 4 weeks of the Screening&#xD;
                  visit)&#xD;
&#xD;
               -  Viral load of less than or equal to 200 cells/mm3 within 12 months of screening&#xD;
                  (per medical record review)&#xD;
&#xD;
               -  CD4+ count greater than 200 cells/mm3 within 12 months of screening (per medical&#xD;
                  record review)&#xD;
&#xD;
             HIV negative (-): Negative HIV status will be confirmed by an on-site rapid HIV test&#xD;
             at screening.&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
          5. Women who are pregnant or breast feeding will not be eligible for this study; a urine&#xD;
             pregnancy test will be performed in women of child-bearing potential within one day of&#xD;
             the PET/CT scan.&#xD;
&#xD;
          6. At screening, the participant's weight is &gt; 350 lb.&#xD;
&#xD;
          7. Subjects who report claustrophobia, which in the opinion of an investigator would&#xD;
             interfere with acquisition of the structural MRI required for PET co-registration,&#xD;
             and/or the PET scan itself.&#xD;
&#xD;
          8. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not&#xD;
             MRI compatible). An MRI screening form will be completed during screening.&#xD;
&#xD;
          9. Screening lab values that indicate significant organ dysfunction that in the opinion&#xD;
             of an investigator could compromise participant safety or successful participation in&#xD;
             the study.&#xD;
&#xD;
         10. History of epilepsy or seizure disorder as assessed by medical record review and/or&#xD;
             self-report&#xD;
&#xD;
         11. History of head trauma that in the opinion of an investigator may interfere with the&#xD;
             uptake of applicable radiotracer as assessed by medical record review and/or&#xD;
             self-report&#xD;
&#xD;
         12. History of schizophrenia or psychotic disorder DSM-5 diagnosis&#xD;
&#xD;
         13. Current DSM-5 diagnosis of untreated/unstable panic disorder, bipolar disorder, PTSD,&#xD;
             eating disorder, major depression (if stable for &gt;30 days, eligible with clinician&#xD;
             approval)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob Dubroff, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin Schubert</last_name>
    <phone>215-662-3041</phone>
    <email>erinschu@pennmedicine.upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erin Schubert</last_name>
      <phone>215-573-6569</phone>
      <email>Erin.Schubert@uphs.upenn.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroinflammatory Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401917
org study id: 842717
nct id: NCT04401917
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
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.
Opioids have direct effects on immune function and opioid receptors are expressed on immune
      cells, including T cells, B cells, macrophages, and microglia (3, 4). There is abundant
      evidence that opioids dysregulate CNS immune function (5-7). However, opioids' effects on
      immune function are complex, with both pro-inflammatory and immune suppressive effects having
      been reported (8, 9). Although the immunosuppressive effects of opioids can increase
      susceptibility to infection (6, 7), individuals with Opioid Use Disorder (OUD) have also been
      found to have higher levels of inflammation than healthy controls (HCs) (10, 11). Opioids
      have also been shown to enhance the expression of inducible nitric oxide synthase (iNOS), a
      marker of oxidative stress, effects that are reversed by NOS inhibitors and in iNOS knockout
      mice (12, 13). Increased expression of iNOS may also be a marker of morphine-induced
      microglial activation and long-term neurochemical changes in the brains of individuals with
      OUD may be due to elevated cytokine and NO levels via iNOS expression (14).

      OUD is frequently accompanied by syndemic comorbidities, such as HIV infection (15). HIV
      infection itself is associated with neuroinflammation, even among patients receiving
      antiretroviral therapy (ART) (16-18). Thus, HIV may exacerbate the inflammatory effects of
      OUD (19). Indeed, morphine treatment alone decreases expression of iNOS by microglia (vs.
      control), but morphine and HIV in combination substantially increase iNOS expression beyond
      the effect of HIV alone (20). This study proposes to use [18F]NOS PET/CT imaging to evaluate
      neuroinflammation in HIV-positive and HIV-negative subjects with OUD, HIV-positive subjects
      without OUD, and HCs.

      In dynamic PET/CT, kinetic analysis of the dynamic time-course of the radiotracer uptake is
      used to help distinguish delivery of the radiotracer from retention. For quantitation of
      dynamic studies, the time-course of uptake is most accurately determined when there is direct
      information available about the time-course of the radiotracer in the blood. This information
      is used to delineate the data obtained from PET imaging and can lead to better image-derived
      variables for study. The gold standard for kinetic modeling relies on having the time-course
      of the radiotracer in the arterial blood as an input to create an arterial input function
      (AIF) (21). To obtain direct arterial blood measurements, an arterial catheter is commonly
      placed in the radial artery of the wrist. Short-term arterial catheterization in healthy
      research subjects was reported to be safe with a low incidence of complications in 1,132
      radial artery catheterizations performed for the purpose of PET research protocols (1
      instance of symptomatic thrombotic occlusion was documented and resolved without intervention
      within weeks of the occurrence) by Everett et al (22).

      Arterial catheterization is a laborious procedure requiring specialized training and often
      discourages people from participating in clinical studies. There may be alternative methods
      of creating an input function using venous blood sampling and/or image-derived input
      functions utilizing more limited blood sampling. Generally, arterial tracer kinetics are
      different from venous kinetics (23). It may be possible to substitute venous samples for
      arterial samples when taken during a transient equilibrium phase. Because the time at which
      this equilibrium is reached differs between tracers and often between species, it cannot be
      generalized. Thus, there is a limited time window of variable length that must be assessed
      individually for each new radiotracer by first sampling arterial blood to allow for
      correlation of the time course information. In addition, almost all radiotracers used in
      brain imaging produce variable amounts of radiometabolites. Imaging alone cannot distinguish
      the parent compound from its radioactive metabolites and plasma radioactivity from that of
      whole blood, and in most cases it is necessary to collect blood samples to correct for
      metabolites when performing kinetic modeling of image data. One potential way to estimate
      radiometabolite concentrations without arterial sampling is by using late venous blood
      samples, when the metabolite concentration is maximal and arterio-venous equilibrium has been
      reached. This approach must be validated for each new radiotracer as the relative
      concentrations of radiometabolites in venous and arterial blood may differ significantly and,
      therefore, venous samples do not accurately estimate arterial metabolite concentrations (21).
      However, whole-body dynamic imaging scans may not require arterial blood as an input to
      create an AIF, and consequently, venous blood can be used as an alternative to measure
      metabolites when the arterial blood pool is within the imaging field of view. Venous blood
      sampling is the preferred approach when working with some populations (e.g., IV drug users).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan
time frame: 3 years
description: comparing the patterns of [18F]NOS brain uptake in OUD+ vs. OUD- subjects using PET/CT scan. Comparing the whole brain [18F]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.
measure: Comparing the patterns of [18F]NOS brain uptake in HIV+ vs. HIV- subjects using PET/Ct scna
time frame: 3 years
description: Comparing the patterns of [18F]NOS brain uptake in HIV+ vs. HIV- using PET/CT scan. Comparing the whole brain [18F]NOS DVR response using a two-way ANCOVA. The primary factors in the model will be two two-level factors, one indicating presence/absence of OUD, and the other presence/absence of HIV.
measure: Compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status.
time frame: 3 years
description: compare patterns of [18F]NOS brain uptake as a function of the interaction of OUD and HIV status
measure: Compare patterns of [18F]NOS brain uptake in regions implicated in HIV and OUD
time frame: 3 years
description: The magnitude of inducement of NOS due to OUD or HIV as measured in uptake of [18F]NOS will be estimated as the absolute difference in SUV or VT values from the corresponding left and right brain regions.
measure: Comparing peripheral blood inflammatory biomarkers as a function of both the main and interactive effects of OUD and HIV status
time frame: 3 years
description: using the peripheral blood inflammatory biomarkers collected during the PET/CT scan and comparing this biomarker as a function of both the main and interactive effects of OUD and HIV status.
arm group label: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)
arm group type: Other
description: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD): HIV+/OUD+
arm group label: HIV negative (HIV-) subjects with OUD
arm group type: Other
description: HIV negative (HIV-) subjects with OUD: HIV-/OUD+
arm group label: HIV Positive (HIV+) subjects with OUD negative
arm group type: Other
description: HIV+ subjects who may have been opioid-exposed but do not have current or past OUD
arm group label: Healthy volunteer
arm group type: Other
description: HIV-, OUD- healthy controls who have been opioid-exposed but do not have current or past OUD
intervention type: Drug
intervention name: [18F]NOS
description: Participants will undergo approximately 60 minutes of dynamic whole-body scanning, including the brain, starting at approximately 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.
arm group label: HIV Positive (HIV+) subjects with OUD negative
arm group label: HIV negative (HIV-) subjects with OUD
arm group label: HIV positive (HIV+) subjects with Opioid Use Disorder (OUD)
arm group label: Healthy volunteer
other name: [18F]-6-(2-fluoro-propyl)-4-methylpyridin-2-amine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob Dubroff, MD, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Erin Schubert
phone: 215-662-3041
email: erinschu@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Neuroinflammatory Diseases