N/A
Completed N=1,731
Opioid Use Disorder in the Emergency Department: CTN 0069
Source: ClinicalTrials.gov NCT03023930 ↗Enrolled (actual)
1,731
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Implementation (Considered the Primary Outcome) — 2; 53 Participants — p=<0.001
Summary
The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implementation (Considered the Primary Outcome) |
2; 53 | <0.001 sig |
| PRIMARY Effectiveness |
40; 59 | 0.011 sig |
| SECONDARY Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score |
— | — |
Eligibility Criteria
Patient Inclusion Criteria:
- Patients who are treated in the ED during study screening hours with Diagnostic and Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid positive urine sample will be eligible to participate.
Patient Exclusion Criteria:
- Patients who test positive for fentanyl only are not eligible due to lack of uniformly available rapid urine tests.
- Patients will be excluded if they have a medical or psychiatric condition requiring hospitalization at the index ED visit, are acutely suicidal or severely cognitively impaired precluding informed consent, present from an extended care facility, require continued prescription opioids for a pain condition, are a prisoner or in police custody at time of index ED visit, are currently (past 30 days) enrolled in formal addiction treatment including by court order, are unable to provide 2 contact numbers, are unwilling to follow study procedures, have been previously enrolled in the current study or do not speak English.
ED and Community Participants Inclusion Criteria:
- ED and community providers and administrators (i.e. physicians, residents, fellows, nursing, nurse practitioners, physician assistants, pharmacists, social workers, counselors, administrative directors, office-based physicians and opioid treatment program representatives) as well as ED patients with OUD.
Data sourced from ClinicalTrials.gov (NCT03023930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.