YORS for Opioid Use Disorder

(YORS Trial)

Overseen By Kevin Wenzel, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Potomac Health Foundations

Must be taking: XR-NTX, XR-BUP

Disqualifiers: Psychiatric instability, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

150 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves treatment with specific medications (XR-NTX or XR-BUP), it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the Youth Opioid Recovery Support (YORS) treatment for opioid use disorder?

The YORS treatment is designed to improve engagement and medication adherence in young adults with opioid use disorder by using strategies like home delivery of medications and assertive outreach. Initial feedback from patients and staff is positive, suggesting it may be a promising approach to enhance care and reduce opioid relapse. ^{1 2 3 4 5}

Is the Youth Opioid Recovery Support (YORS) intervention safe for humans?

The available research on the Youth Opioid Recovery Support (YORS) intervention does not provide specific safety data, but it has been used in studies with young adults for opioid use disorder, suggesting it is generally considered safe for this population. ^{1 2 3 4 5}

How is the YORS treatment different from other treatments for opioid use disorder?

The YORS treatment is unique because it focuses on improving adherence to extended-release medications for opioid use disorder through assertive outreach and home delivery, making it easier for young adults to stay engaged in their treatment. It also adapts to challenges like the COVID-19 pandemic by using mobile van delivery to reduce exposure risks. ^{1 2 3 4 6}

Research Team

Marc Fishman, MD

Principal Investigator

Maryland Treatment Centers

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stakeholder Input and Pilot Testing

Conduct stakeholder focus groups and 3 cycles of pilot testing for intervention refinements

8-12 weeks

Randomized Controlled Trial (RCT)

Participants are randomized to either the refined YORS intervention or treatment as usual (TAU) for a 6-month course of treatment with XR-NTX

26 weeks

Data measured every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Youth Opioid Recovery Support (YORS)

Trial Overview 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.

Participant Groups

Group I: Youth Opioid Recovery Support (YORS) Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

Potomac Health Foundations

Lead Sponsor

Trials

7

Recruited

490+

Friends Research Institute, Inc.

Collaborator

Trials

60

Recruited

22,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The youth opioid recovery support (YORS) intervention significantly improved adherence to extended-release naltrexone (XR-NTX), with participants receiving an average of 4.28 doses compared to only 0.70 doses in the standard treatment group over 24 weeks.

Participants in the YORS group had a much lower relapse rate (61%) compared to the treatment as usual group (95%), indicating that YORS not only enhanced medication adherence but also effectively reduced the likelihood of returning to opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Fishman, M., Wenzel, K., Vo, H., et al.[2021]

A study involving 35 youth with opioid use disorders explored their preferences for outpatient treatment options, revealing that they value both intensive outpatient treatment (IOP) and community-based 12-step groups for different reasons.

Key themes identified included the importance of structured recovery support, mechanisms of accountability, and the significance of relationships, indicating that both treatment approaches offer unique benefits that may be complementary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-residential treatment outpatient care preferences: Perspectives of youth with opioid use disorder. Monico, LB., Ludwig, A., Lertch, E., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Age disparities in six-month treatment retention for opioid use disorder. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Post-residential treatment outpatient care preferences: Perspectives of youth with opioid use disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Medication Treatments for Youth and Young Adults With Opioid Use Disorder. [2022]