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SafetyNet Program for Opioid Use Disorder (OUD)
NA trial testing Team Intervention in Opioid-Use Disorder (OUD) in 81 participants. Completed in 20 April 2022.
| Lead sponsor | Yale University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 1 July 2020 |
| Primary completion | 20 April 2022 |
| Estimated completion | 20 April 2022 |
| Sites | 2 locations across United States |
Yale University
Adults 18 to 130, any sex, with Opioid-Use Disorder (OUD). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Count of positive urine tests at 30 days after intervention per patient (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 35 | |
| SafetyNet With Successful Follow Ups | 45 | |
| SafetyNet Without Successful Follow Ups | 1 | |
| SafetyNet With Successful Follow Ups | 0 |
Count of positive urine tests at 180 days after intervention per patient (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 31 | |
| SafetyNet With Successful Follow Ups | 42 | |
| SafetyNet Without Successful Follow Ups | 2 | |
| SafetyNet With Successful Follow Ups | 3 | |
| SafetyNet Without Successful Follow Ups | 1 | |
| SafetyNet With Successful Follow Ups | 0 | |
| SafetyNet Without Successful Follow Ups | 1 | |
| SafetyNet With Successful Follow Ups | 0 |
Count of Emergency Department Overdose(s) at 30 days after intervention per patient (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 32 | |
| SafetyNet With Successful Follow Ups | 39 | |
| SafetyNet Without Successful Follow Ups | 2 | |
| SafetyNet With Successful Follow Ups | 3 | |
| SafetyNet Without Successful Follow Ups | 2 | |
| SafetyNet With Successful Follow Ups | 2 | |
| SafetyNet Without Successful Follow Ups | 0 | |
| SafetyNet With Successful Follow Ups | 1 |
Count of Emergency Department Overdose(s) at 180 days after intervention per patient (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 27 | |
| SafetyNet With Successful Follow Ups | 34 | |
| SafetyNet Without Successful Follow Ups | 5 | |
| SafetyNet With Successful Follow Ups | 4 | |
| SafetyNet Without Successful Follow Ups | 0 | |
| SafetyNet With Successful Follow Ups | 4 | |
| SafetyNet Without Successful Follow Ups | 2 | |
| SafetyNet With Successful Follow Ups | 1 |
Percentage of patients engaged in Medication Assisted Therapy (MAT) within 180 days after intervention (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 23 | |
| SafetyNet With Successful Follow Ups | 32 |
Percentage of patients with any use of Suboxone within 180 days after intervention (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 10 | |
| SafetyNet With Successful Follow Ups | 19 |
Percentage of patients with at least 1 positive urine test at 30 days after intervention (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 1 | |
| SafetyNet With Successful Follow Ups | 0 |
Percentage of patients with at least 1 positive urine test at 180 days after intervention (data obtained via chart review)
| Group | Value | 95% CI |
|---|---|---|
| SafetyNet Without Successful Follow Ups | 5 | |
| SafetyNet With Successful Follow Ups | 3 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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