Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Opioid Use Disorder (OUD)

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

FieldValue
Enrollment Target 81 participants
Start Date 2020-07-01
Est. Completion 2022-04-20
Phase NA

Sponsor

Yale University

1,492 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04253782

The ClinicalTrials.gov registry entry for NCT04253782 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 306-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (74% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Opioid Use Disorder (OUD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Opioid Use Disorder (OUD)

All registered trials for this condition

Connecticut

All trials with a study site in Connecticut

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.