N/A
N=81
SafetyNet Program for Opioid Use Disorder (OUD)
Opioid-Use Disorder (OUD)
Bottom Line
View on ClinicalTrials.gov: NCT04253782 ↗Enrolled (actual)
81
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Frequency of Positive Urine Tests at 30 Days (Chart Review) — 35; 45; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Team Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Positive Urine Tests at 30 Days (Chart Review) |
35; 45; 1; 0 | — |
| PRIMARY Frequency of Positive Urine Tests at 180 Days (Chart Review) |
31; 42; 2; 3; 1; 0 | — |
| PRIMARY Frequency of Emergency Department Overdose(s) at 30 Days (Chart Review) |
32; 39; 2; 3; 2; 2 | — |
| PRIMARY Frequency of Emergency Department Overdose(s) at 180 Days (Chart Review) |
27; 34; 5; 4; 0; 4 | — |
| PRIMARY Percentage of Patients Engaged in Medication Assisted Therapy (MAT) Within 180 Days (Chart Review) |
23; 32 | — |
| PRIMARY Percentage of Patients With Any Use of Suboxone Within 180 Days (Chart Review) |
10; 19 | — |
| PRIMARY Frequency of Positive Urine Tests Within 30 Days (Self-report) |
— | — |
| PRIMARY Frequency of Positive Urine Tests Within 180 Days (Self-report) |
— | — |
| SECONDARY Percentage of Positive Urine Tests at 30 Days (Chart Review) |
1; 0 | — |
| SECONDARY Percentage of Positive Urine Tests at 180 Days (Chart Review) |
5; 3 | — |
| SECONDARY Percentage of Positive Urine Tests Within 30 Days (Self-report) |
— | — |
| SECONDARY Percentage of Positive Urine Tests Within 180 Days (Self-report) |
— | — |
Summary
The principal aim of this study is to determine whether a novel biopsychosocial intervention following opioid overdose (OD) affects 1) the frequency of secondary opioid OD events and 2) the proportion of individuals who remain engaged in treatment for opioid use disorder (OUD) or are in remission at 30 days and at 180 days post intervention. Remission is defined as engagement in daily medication-assisted therapy (MAT)-typically buprenorphine/naloxone (BUP) or methadone- and/or a recovery capital score of ≥ 27.5. The intervention principally involves connecting OUD-affected individuals with community resources, including BUP-, other MAT-, and education-related services. To carry out the intervention, an addiction recovery coach and an appropriately trained health educator paramedic (research assistant) will form a Team and perform follow-up visits (electronically/remotely and/or by phone and/or in person, when appropriate) after a participant has experienced at least 1 opioid OD requiring naloxone resuscitation. Our hypothesis is that the intervention will decrease subsequent OD events and increase the likelihood of remission. To evaluate this hypothesis, data will be collected from self-report and from EPIC, Yale New Haven Hospital's medical record system. The secondary aim is to determine whether the intervention affects 1) the frequency of positive-urine tests for opioids and 2) the frequency and proportion of subjects self-reporting opioid use. Our hypothesis is that this intervention will decrease both. Data from the entire cohort will be compared in aggregate with patients who were started on BUP in the ED over the same time period and with historic controls.
Eligibility Criteria
Inclusion criteria
- ≥18 years
- Screen positive for opioid use disorder (OUD)
- Screen positive for OUD using the mini international neuropsychiatric interview (MINI)
- At least 1 opioid overdose requiring resuscitation by naloxone or equivalent
- No non-opioid overdose explanation for decreased level of consciousness, miosis, or decreased respiratory rate
- Positive for OUD using a health questionnaire containing questions about prescription opioid and heroin use
- Not in a critically ill state at the time of consent (e.g., not actively suicidal, psychotic, septic, nor cardiac arrest; nor any combination; nor equivalent)
- 3., 4., & 6. (in III. Inclusion criteria) must have occurred within ≤7 days (inclusive) from the date of consent if the prospective participant were discharged from the hospital or equivalent treatment facility
- Not homicidal
- Able to self-consent to program/study participation
- Permanent residence is not a long-term care facility
- No simultaneous enrollment in another study whose principal investigator (PI) or co-PI is a faculty member in the Department of Emergency Medicine at the Yale School of Medicine
- Not prescribed opioids for acute pain, chronic pain, or palliative care without OUD diagnosis
- Not stably enrolled in opioid agonist treatment for OUD at the time of the ED visit
- Neither in police custody nor incarcerated nor both; nor equivalent; *parolees and those on probation may be enrolled incidentally, but are not the target population of this work
- Refused buprenorphine/naloxone (BUP), if offered
- Has a valid mailing address or P.O. box
- Able to answer questions electronically/remotely, by phone, or by any combination of these technologies
Exclusion criteria
- 7 days (exclusive) from the date of consent if the prospective participant were discharged from the hospital or equivalent treatment facility
- Homicidal
- Unable to self-consent to program/study participation
- Permanent resident of a long-term care facility
- Simultaneous enrollment in another study whose principal investigator (PI) or co-PI is a faculty member in the Department of Emergency Medicine
- Prescribed opioids for acute pain, chronic pain, or palliative care without OUD
- Stably enrolled in opioid agonist treatment or other medication-assisted therapy for OUD at the time of consent
- In police custody and/or incarcerated or equivalent; *parolees and those on probation may be enrolled incidentally, but are not the target population of this work
- On BUP treatment
- No valid mailing address or P.O. box
- Unable to answer questions electronically/remotely, by phone, or by any combination of these technologies
Data sourced from ClinicalTrials.gov (NCT04253782). 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.