Youth Opioid Recovery Support for Opioid Use Disorder

(YORS Trial)

Overseen By Kevin Wenzel, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Potomac Health Foundations

Must be taking: Sublingual buprenorphine

Disqualifiers: Psychiatric instability, Homelessness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 26 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Despite rising rates of fatal opioid overdoses in the United States, adolescents with OUD are far less likely than adults to receive and be retained on medication for opioid use disorder (MOUD). The multicomponent Youth Opioid Recovery Support (YORS) intervention for young adults seeks to increase adherence to extended-release MOUD and reduce opioid relapse through family involvement, assertive outreach, low-barrier access to MOUD, and contingency management. By expanding investigations of the evidence based YORS intervention to adolescents, especially those on sublingual buprenorphine, this project will significantly contribute to our knowledge base of practical strategies to address the opioid crisis in youth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be considering or have recently started certain opioid use disorder treatments, so 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 Youth Opioid Recovery Support (YORS) treatment has shown promise in improving adherence to medications for opioid use disorder (OUD) and reducing relapse through assertive outreach techniques. Initial feedback from patients and staff on strategies like home delivery and mobile van services for medication has been positive, suggesting these methods may enhance treatment engagement. ^{1 2 3 4 5}

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

The Youth Opioid Recovery Support (YORS) intervention has been tested with extended-release medications like naltrexone and buprenorphine for young adults with opioid use disorder, and initial feedback from patients and staff is positive, suggesting it is generally safe for use in humans. ^{1 2 3 6 7}

What makes the Youth Opioid Recovery Support (YORS) treatment unique for opioid use disorder?

The Youth Opioid Recovery Support (YORS) treatment is unique because it combines assertive outreach techniques with home delivery of extended-release medications like buprenorphine and naltrexone, aiming to improve medication adherence and reduce relapse in young adults. It also incorporates family involvement and telehealth strategies to enhance engagement and support throughout the treatment process. ^{1 2 3 8 9}

Eligibility Criteria

This trial is for adolescents struggling with Opioid Use Disorder (OUD). Participants should be young individuals who have difficulty sticking to their medication treatments. The study aims to help them by involving families, providing easy access to treatment, and offering incentives for staying on track.

Inclusion Criteria

English speaking

Provision of signed and dated informed assent form (may be collected verbally over audio and/or video platform in the event of a remote enrollment)

I am willing to have a guardian consent for me if needed.

Exclusion Criteria

Adolescent patients with OUD:

I share my medications with a teenager.

Treatment Significant Other (TSO) Participants:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the YORS intervention for 26 weeks to enhance adherence to MOUD

26 weeks

Bi-weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Youth Opioid Recovery Support (YORS)

Trial Overview The Youth Opioid Recovery Support (YORS) intervention is being tested. It's designed to improve adherence to opioid addiction medications and reduce the chance of relapse in adolescents using a combination of family support, proactive outreach, simplified access to medication, and rewards for compliance.

Participant Groups

Group I: Youth Opioid Recovery Support (YORS) Experimental Treatment 1 Intervention

All adolescent patient participants and their treatment significant other (TSO) participants will be assigned to the YORS intervention condition for 26 weeks of treatment. YORS is an innovative wrap-around approach that attempts to enhance adherence to medication for opioid use disorder (MOUD) for adolescents with OUD. The intervention will begin upon confirming eligibility and interest in the study through screening and informed consent processes. Participants will be maintained in the YORS arm and continue to receive assertive outreach in attempts to re-engage them for the duration of the intervention period unless the withdraw from the study or are otherwise removed.

Who Is Running the Clinical Trial?

Potomac Health Foundations

Lead Sponsor

Trials

7

Recruited

490+

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. 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]

3. 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]

4. Ireland pubmed.ncbi.nlm.nih.gov

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

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

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

6. Australia pubmed.ncbi.nlm.nih.gov

Treatment approaches and outcome trajectories for youth with high-risk opioid use: A narrative review. [2022]

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

Interventions to Reduce Opioid Use in Youth At-Risk and in Treatment for Substance Use Disorders: A Scoping Review. [2022]

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

Conceptual framework for telehealth strategies to increase family involvement in treatment and recovery for youth opioid use disorder. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improving Treatment Together: a protocol for a multi-phase, community-based participatory, and co-design project to improve youth opioid treatment service experiences in British Columbia. [2021]