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NCT04253782 · ClinicalTrials.gov registry record · NA
SafetyNet Program for Opioid Use Disorder (OUD)
A NA study of Opioid Use Disorder (OUD), sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
- 2
- Study locations
NCT04253782: Completed NA study of Opioid Use Disorder (OUD), sponsored by Yale University.
NCT04253782 is a NA study of Opioid Use Disorder (OUD) that has completed, run by Yale University. The registered enrollment target is 81 participants, below the 306-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04253782, a NA study of Opioid Use Disorder (OUD), has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Count of positive urine tests at 30 days after intervention per patient (data obtained via chart review)
Conditions Studied
Interventions
- OTHER Team Intervention
Study Locations (2)
Connecticut
- Yale New Haven Hospital, 20 York Street - New Haven
- Yale New Haven Hospital, Saint Raphael Campus, 1450 Chapel Street - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-04-20 |
| Phase | NA |
What the finished NCT04253782 record still lists
NCT04253782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 306-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Opioid Use Disorder (OUD) appearing as the primary indexed condition, and to 1 intervention - of which Team Intervention is the first listed.
NCT04253782 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04253782 about?
NCT04253782 is a clinical study titled "SafetyNet Program for Opioid Use Disorder (OUD)". 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...
What is the current status of trial NCT04253782?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2020-07-01. Estimated completion is 2022-04-20.
What conditions does trial NCT04253782 study?
This clinical trial studies the following conditions: Opioid Use Disorder (OUD).
What interventions are being tested in trial NCT04253782?
The interventions under investigation include: Team Intervention (OTHER).
Who is sponsoring clinical trial NCT04253782?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04253782 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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