The Youth Opioid Recovery Support (YORS) Intervention
YORS
1 other identifier
interventional
150
1 country
1
Brief Summary
Youth are disproportionately affected by the current opioid crisis with catastrophic consequences, and young adults with opioid use disorder (OUD) often struggle with adherence to relapse prevention medications. The Youth Opioid Recovery Support (YORS) model is a promising, innovative, wrap-around approach that addresses barriers to medication adherence and treatment engagement in an effort to improve public health outcomes in this vulnerable young adult population. This study seeks to refine the YORS intervention through stakeholder input and pilot iterative testing followed by an efficacy randomized controlled trial. This project will significantly contribute to our knowledge base of practical strategies to address the opioid crisis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
September 24, 2025
September 1, 2025
6.5 years
November 20, 2019
September 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of MOUD injections received (XR-NTX or XR-BUP)
Total number of injections received within 26 weeks
Treatment week 0 to 26 weeks
Rate of opioid relapse during the study period
Relapse = 10 days of use within a 28 day period. Days of opioid use will be assessed through urine toxicology and self report methods.
Time Frame: Data measured every 2 weeks for the duration of the 26-week study period
Study Arms (2)
Youth Opioid Recovery Support (YORS)
EXPERIMENTALThe Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence. The specific components of YORS will be refined and adapted based on feedback from interviews and focus groups with various stakeholders. However, the basic framework outlined above is expected to persists.
Treatment As Usual
NO INTERVENTIONTAU will contain patients who will be receiving treatment for opioid use disorder through their usual venues without the family engagement, assertive outreach, contingency management, and home delivery of medication. This often includes a referral and warm hand off to intensive outpatient SUD services and/or mental health care.
Interventions
The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence.
Eligibility Criteria
You may qualify if:
- Age 18-28
- OUD diagnosis
- Willing (intending) to receive treatment with XR-NTX or XR-BUP under the care of a MTC physician/nurse practitioner
- Willingness to designate family member (or other suitable treatment significant other) for treatment involvement (i.e., a treatment significant other; TSO)
You may not qualify if:
- Psychiatric or medical instability (e.g., suicidality, psychosis, Sickle Cell disease with frequent crises) that would preclude participation in the trial
- Living situation (location greater than 75 miles from the center, homelessness) that would preclude participation in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Potomac Health Foundationslead
- National Institutes of Health (NIH)collaborator
- Friends Research Institute, Inc.collaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Mountain Manor Treatment Center
Baltimore, Maryland, 21229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Fishman, MD
Maryland Treatment Centers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 22, 2019
Study Start
February 17, 2020
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share