CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Team Interventionother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04253782
NCT04253782N/ACompleted

A Multi-Tiered Safety Net Following Naloxone Resuscitation From Opioid Overdose

Yale University·interventional·Posted Feb 5, 2020·Updated Oct 18, 2024

In Brief

A clinical study evaluating Team Intervention for Opioid-Use Disorder (OUD). Completed, enrolled 81 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 5, 2020
Enrollment StartJul 1, 2020
Primary CompletionApr 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.4 years ago

Interventions

Team Interventionother

The Team will meet with participants (remotely/electronically and/or by phone) and will ask that they select one of three options that may help with opioid addiction: 1. treatment with buprenorphine/naloxone (BUP), 2. inpatient, 12-step, or methadone regimens, or 3. education only (materials provided by the CT Community for Addiction Recovery (CCAR)). Throughout the study, participants may switch to any other option.