YORS for Opioid Use Disorder
(YORS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMarc Fishman, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Potomac Health Foundations

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for young adults aged 18-28 with opioid use disorder who are willing to take relapse prevention medications and involve a family member or significant other in their treatment. It's not suitable for those living too far from the center, experiencing homelessness, or dealing with severe psychiatric or medical conditions.

Inclusion Criteria

I am willing to receive XR-NTX or XR-BUP treatment from a specialized doctor or nurse.

I am willing to involve a family member or someone close in my treatment.

OUD diagnosis

+1 more

Exclusion Criteria

I do not have severe mental health issues or unstable medical conditions that would stop me from joining the trial.

Living situation (location greater than 75 miles from the center, homelessness) that would preclude participation in the trial

Participant Groups

The YORS intervention is being tested to see if it helps young adults stick to their medication plans and stay engaged in treatment. The study includes refining the program through feedback and then testing its effectiveness compared to standard care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Youth Opioid Recovery Support (YORS)Experimental Treatment1 Intervention

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.

Group II: Treatment As UsualActive Control1 Intervention

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.