Recruiting

YORS

Sponsor:

Potomac Health Foundations

Code:

NCT04173416

Conditions

Opioid-use Disorder

Medication Adherence

Eligibility Criteria

Sex: All

Age: 18 - 28

Healthy Volunteers: Not accepted

Interventions

Youth Opioid Recovery Support (YORS)

Study Details

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.

Conditions

Opioid-use Disorder

Medication Adherence

Study ID

NCT04173416

Start date

Feb 17, 2020

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 28

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Youth Opioid Recovery Support (YORS)

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.

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.

no intervention: Treatment As Usual

TAU 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

Youth Opioid Recovery Support (YORS)

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.

Primary outcome measure

  • Number of MOUD injections received (XR-NTX or XR-BUP) [ Time Frame: Treatment week 0 to 26 weeks ]
  • Rate of opioid relapse during the study period [ Time Frame: Time Frame: Data measured every 2 weeks for the duration of the 26-week study period ]

Central Contacts and Locations

Central contacts

Marc Fishman, MD

410-233-1400mjfishman@comcast.net

Kevin Wenzel, PhD

410-233-1400kwenzel@mountainmanor.org

Locations

Mountain Manor Treatment Center

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

Kevin Wenzel, PhD

4102331400kwenzel@mountainmanor.org

Marc Fishman, MD

4102331400mfishman@marylandtreatment.org

More Information

Sponsor

Potomac Health Foundations

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Potomac Health Foundations on 2025-09-24.