Youth Opioid Recovery Support: Improving Care Systems (YORS)

January 22, 2022 updated by: Victoria Selby, University of Maryland, Baltimore

Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder

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 patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Mountain Manor Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young adults, ages 18-26, admitted to residential/inpatient addiction treatment
  • Meets DSM-5 criteria for opioid use disorder
  • Has used opioids other than specifically prescribed within 30 days prior to consent
  • Has selected treatment with extended-release naltrexone or extended-release buprenorphine
  • Is prescribed extended-release naltrexone or extended-release buprenorphine under the care of a Mountain Manor Treatment Center physician or nurse practitioner
  • Willing to designate one or more family members of their choice to be involved with their treatment.
  • Family Participant: must be at least 18 years old, be designated by the patient Participant, and willing to be involved in the treatment.

Exclusion Criteria:

  • Living situation is beyond a reasonable travel distance from the treatment center
  • Currently, in jail, prison, or any inpatient overnight facility as required by course of law or have a pending legal action which may prevent an individual from completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Youth Opioid Recovery Support service model
The components of the Youth Opioid Recovery Support service model includes 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 medication treatment.
Behavioral: Youth Opioid Recovery Support service model
see arm 1 description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in medication-assisted treatment of opioid use disorder
Time Frame: Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
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
Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
Opioid relapse
Time Frame: Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
Opioid Relapse is defined as 10 days of opioid use within a 28-day period. Days of opioid use are calculated using data from self report and urine toxicology with missing or positive urine specimens imputed as 5 days of use.
Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
Total number of opioid positive drug screens
Time Frame: Every 2 weeks for the duration of enrollment, up to 36 weeks.
Urine drug screening will objectively determine opioid use or nonuse.
Every 2 weeks for the duration of enrollment, up to 36 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in behaviors related to recovery
Time Frame: Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
Participant-reported behaviors associated with function (e.g., employment), legal involvement, HIV risk behavior, overdoses, and crisis utilization (emergency room visit, hospitalization, detoxification services).
Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
Continued receipt of care post-intervention
Time Frame: Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.
Receipt of medication-assisted treatment at the treatment center after the last dose of home-delivered medication.
Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Marc Fishman, MD, Mountain Manor Treatment Center
  • Study Director: Kevin Wenzel, PhD, Mountain Manor Treatment Center
  • Principal Investigator: Victoria Selby, PhD, University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2019

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-0085682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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