Table 1 Table of assessments

General measures

Prescreen Approach Log

X

Verbal Consent

X

Prescreening Form

X

Written Informed Consent and Quiz

X

Inclusion/Exclusion

X

Locator Form

X

X

X

PhenX [30] Core Tier 1 Forms

X

Demographics Forms

X

Treatment Satisfaction Survey

X

Treatment Initiation and Non-Initiation

X

Hospitalization MOUD

X

Marijuana Use Assessment

X

COVID-19 Impact Assessment

X

X

X

X

Timeline Followback (TLFB) (Medications)

X

X

X

Study Completion Form

X

Measure of Primary and Secondary Outcomes

Engagement in MOUD Post Hospital Discharge

X

X

X

Hospitalization and ED Utilization (Related or Not to OUD)

X

X

X

Urine Drug Screen

X

X

X

X

Timeline Followback (TLFB) (Drug/Alcohol) [31, 32]

X

X

X

X

Clinical and safety assessments

Medical and Psychiatric History

X

Physical Examination

X

Injection Site Examination^b

X

X

Injection Site Reaction Form^c

X

X

X

Hospitalization Diagnoses

X

Medical Comorbidity [33]

X

Vital Signs

X

DSM-5 Checklist [35]

X

Mental Health Follow-Up Assessment

X

Adverse Events, Including Serious Adverse Events

X^d

X

X

X

X

X^e

Prior and Concomitant Medications

X

X

X

X

Clinical Opioid Withdrawal Scale^{b; f} [34]

X

Clinical laboratory assessments

Pregnancy and Birth Control Assessment^g

X

Confirmed Pregnancy and Outcome

X

Liver Transaminases (AST and ALT)^h

X

Hepatitis B, Hepatitis C, HIV Antibody^h

X

X

Genetic Sampling^h

X

X

X

X

X

Family Origin

X

Exploratory measures

Healthcare and Services Utilization [36]

X

X

X

Pain Assessment [37]

X

X

X

X

Depression (PHQ-9) [38]

X

X

X

X

Post-Traumatic Stress Disorder (PC-PTSD-5) [39]

X

X

X

X

Quality of Life (WHOQOL-BREF) [40]

X

X

Non-Fatal Opioid Overdose

X

X

X

X

Fatal Opioid Overdose (collected on SAE form)

X^d

X

X

X

X

X

Addiction Severity Index-Lite (ASI-Lite) Drug and Alcohol Use [41]

X

X

Post-Hospitalization Medical Appointment Follow-Up

X

X

Antibiotic Adherence for OUD-Related Infectionsⁱ

X

X

Hospital Length of Stay

X

X

X

X

Subsequent XR-BUP Injections (XR-BUP group only)

X

X

X

Receipt of Other MOUD

X

X

X

Administrative forms

Protocol Deviations

X

Missed Visit and Visit Documentation Form

X

X

X

X

X