Tau PET Imaging in Opioid Use Disorder

Inclusion Criteria:

OUD OD- group:

1. 18-60 years-old

2. Informed of the investigational nature of this study and able to provide writteninformed consent and participate in this study in accordance with institutional andfederal guidelines prior to study-specific procedures.

3. Participants meet for lifetime OUD and are currently in medication-assistedtreatment for OUD, which must include being on a stable dose of medication for atleast 30 days prior to the screening visit.

4. No lifetime history of OD per self-report, Drug Overdose Questionnaire, and/ormedical record review.

OUD OD+ group:

1. 18-60 years-old

2. Informed of the investigational nature of this study and able to provide writteninformed consent and participate in this study in accordance with institutional andfederal guidelines prior to study-specific procedures.

3. Participants meet for lifetime OUD and are currently in medication-assistedtreatment for OUD, which must include being on a stable dose of medication for atleast 30 days prior to the screening visit.

4. A history of at least 1 opioid OD that required naloxone reversal that occurred upto 5 years prior to study enrollment, as per self-report, Drug OverdoseQuestionnaire, and/or medical record review.

Healthy Control (HC) group:

1. 18-60 years-old

2. Informed of the investigational nature of this study and able to provide writteninformed consent and participate in this study in accordance with institutional andfederal guidelines prior to study-specific procedures.

3. Must have never met lifetime history for Alcohol Use Disorder, Substance UseDisorder --other than cannabis, tobacco or nicotine use disorder (as per DSM-5) andnot used an opioid for any reason in the 30 days prior to screening by self-report,medical record review, and urine drug testing at screening.

4. Must provide a negative urine drug screen on the day of the screening, MRI and PETscan visits for all substances (other than cannabis).

Exclusion Criteria:

1. HIV infection confirmed by an on-site rapid HIV test at screening. HIV affectneurocognitive function, even in otherwise asymptomatic individuals, which canconfound the results of MRI testing.

2. The urine drug screening & pregnancy test (for women of child-bearing potential) atthe screening visit, MRI visit, and PET/CT scan visits must be negative forpregnancy (all groups) or will be deemed ineligible to participate. Participants inthe healthy control group with a positive drug screen will be ineligible.

3. At screening, the participant's weight is >350 lb.

4. Self-reported claustrophobia, which in the opinion of an investigator wouldinterfere with acquisition of the structural MRI required for PET co-registration,and/or the PET scan itself.

5. Contraindications to MRI (e.g., metal in the body that cannot be removed and is notMRI compatible). An MRI screening form will be completed during screening toidentify contraindications.

6. Screening lab values that indicate significant organ dysfunction that in the opinionof an investigator could compromise participant safety or successful participationin the study.

7. History of epilepsy or seizure disorder (that are not a result of substance use orsubstance withdrawal in OUD+ groups) as assessed by medical record review orself-report.

8. History of head trauma that in the opinion of an investigator may interfere with theuptake of applicable radiotracer as assessed by medical record review orself-report.

9. Current serious psychiatric disorder (bipolar disorder, schizophrenia, psychoticdisorder, eating disorder, or major depressive disorder with suicidal ideation orpsychotic features) identified by medical record review, clinical examination orstructured psychiatric interview that could interfere with study participation ormake it hazardous for the participant or staff to perform study procedures.

10. Self-reported heavy daily use of psychoactive substances in the past 30 days (priorto the screening visit), such as stimulants, cocaine, but not including nicotine,caffeine, cannabis (or opioids in the OUD groups) that could interfere with studyperformance.

11. Not able to provide a breath alcohol level of 0.000 (tested with handheld breathanalyzer) at the screening, MRI and/or PET scan visits.

12. Inability to tolerate imaging procedures as determined by an investigator ortreating physician

13. Any current medical condition, illness, or disorder assessed by medical recordreview and/or self-report that is considered by a physician or investigator topotentially compromise participant safety or their successful participation in thestudy