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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new approach called the Youth Opioid Recovery Support (YORS) model. This model helps young adults with opioid use disorder (OUD) adhere to their treatment plans through home delivery of medication, family involvement, outreach, and incentives. Participants will either receive the YORS treatment or continue with their usual care. This trial suits young adults aged 18-28 with an OUD diagnosis who are open to involving a family member in their treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future treatment strategies.

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 prior data suggests that the YORS model is safe for young adults with opioid use disorder?

Research shows that the Youth Opioid Recovery Support (YORS) model uses innovative methods, such as home delivery of medication and family involvement in treatment. These components aim to help young adults remain committed to their treatment for opioid use disorder (OUD). Although specific safety data for YORS is not yet available, one of its key medications, extended-release naltrexone, has already received FDA approval for treating OUD. This approval indicates that the medication is generally considered safe. Additionally, because the YORS model emphasizes support and outreach without introducing new drugs, it likely presents fewer safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Youth Opioid Recovery Support (YORS) because it offers a fresh approach to helping young adults with opioid use disorder. Unlike standard treatments, which often rely on clinic visits for medication, YORS includes home delivery of extended-release naltrexone, making it easier for patients to stick to their treatment plans. Another standout feature is the active involvement of families in the treatment process, which can improve medication adherence. Additionally, the use of assertive outreach techniques like text messaging and social media keeps patients engaged and on track with their recovery. These innovative components aim to address some of the biggest challenges in treating this vulnerable population and could make a significant difference in their recovery journey.

What evidence suggests that the YORS model is effective for opioid use disorder?

Research has shown that the Youth Opioid Recovery Support (YORS) model, a treatment option in this trial, can significantly assist young adults dealing with opioid addiction. The YORS model improves medication adherence by delivering extended-release naltrexone to participants' homes, which helps reduce opioid cravings. Studies suggest that involving families in treatment, actively reaching out to participants, and offering rewards for adherence help young people remain committed. This approach has shown promise in increasing the number of doses participants take and reducing their opioid use. Overall, YORS aims to simplify treatment adherence for young adults and enhance recovery outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Marc Fishman, MD

Principal Investigator

Maryland Treatment Centers

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04173416

The Youth Opioid Recovery Support (YORS) Intervention ... It is hypothesized that participants in the YORS condition will receive significantly more XR-NTX doses and will demonstrate less severe opioid use and ...

2. heal.nih.gov heal.nih.gov/node/34421

The Youth Opioid Recovery Support (YORS) Intervention The Youth Opioid Recovery Support (YORS) model is an innovative wraparound approach that attempts to address barriers to treatment engagement in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04015115

Youth Opioid Recovery Support: Improving Care Systems The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221000325

Choice of extended release medication for OUD in young ... The YORS intervention aims to improve outcomes for youth with opioid use disorder. · Assertive outreach is used to improve extended release medication adherence.

5. heal.nih.gov heal.nih.gov/news/stories/Youth-Opioid-Recovery

Intervention for Young People Aims to Lift Barriers ... Support system model encourages young adults to access and continue medication-based treatment to achieve long-term recovery.

6. trialx.com trialx.com/clinical-trials/listings/261125/the-youth-opioid-recovery-support-yors-intervention/

The Youth Opioid Recovery Support (YORS) Intervention Young people are disproportionately affected by the current opioid crisis including worse retention and outcomes compared to older adults.