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NCT04015115 · ClinicalTrials.gov registry record · NA

Youth Opioid Recovery Support: Improving Care Systems

A NA study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT04015115: Completed NA study, sponsored by University of Maryland, Baltimore.

NCT04015115 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04015115, a NA study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study Summary

Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment. Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse. MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families. The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment. This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patie

Primary Outcome

Total number of outpatient doses of extended-release naltrexone or extended-release buprenorphine received by the participant between enrollment and the end of the study window

Interventions

  • BEHAVIORAL Youth Opioid Recovery Support service model

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2019-07-26
Est. Completion 2020-10-31
Phase NA
University of Maryland, Baltimore

560 total trials

What the finished NCT04015115 record still lists

NCT04015115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Youth Opioid Recovery Support service model is the first listed.

NCT04015115 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04015115 about?

NCT04015115 is a clinical study titled "Youth Opioid Recovery Support: Improving Care Systems". Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting...

What is the current status of trial NCT04015115?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2019-07-26. Estimated completion is 2020-10-31.

What interventions are being tested in trial NCT04015115?

The interventions under investigation include: Youth Opioid Recovery Support service model (BEHAVIORAL).

Who is sponsoring clinical trial NCT04015115?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04015115's enrollment target sits among peer trials

44 1423rd of 2000 higher than 566 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04015115, the US trial registry maintained by the National Library of Medicine. NCT04015115 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.