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SafetyNet Program for Opioid Use Disorder (OUD)

NCT04253782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-10-18

Study results available
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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.

Conditions

  • Opioid-Use Disorder (OUD)

Interventions

OTHER

Team Intervention

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.

Sponsors & Collaborators

Principal Investigators

  • Daniel Joseph, MD · Yale University School of Medicine, Yale New Haven Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-04-20
Completion
2022-04-20

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253782 on ClinicalTrials.gov