Youth Opioid Recovery Support for Opioid Use Disorder

(YORS Trial)

Overseen By Kevin Wenzel, PhD

Age: < 65

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents with opioid use disorder (OUD) adhere to their medication plans and avoid relapse. It involves the Youth Opioid Recovery Support (YORS) program, which combines family involvement, outreach, easy access to medication, and rewards for staying on track. Teens who might benefit include those diagnosed with OUD, who have recently used opioids, and are considering or have started treatments like buprenorphine. As an unphased trial, it provides a unique opportunity for teens to access comprehensive support tailored to their recovery journey.

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 prior data suggests that the Youth Opioid Recovery Support (YORS) intervention is safe for adolescents?

The Youth Opioid Recovery Support (YORS) program helps young people adhere to their medication plans for opioid use disorder (OUD). It includes family support, proactive outreach, and easy access to treatment. These methods aim to enhance the effectiveness of existing OUD medications, which are known to be safe.

YORS simplifies treatment continuation for adolescents. Although specific safety data from YORS studies is unavailable, the treatment methods it promotes, such as long-lasting OUD medications, have been researched and are generally considered safe when used properly.

In summary, while specific safety information for YORS itself is lacking, its strategies rely on treatments proven to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Youth Opioid Recovery Support (YORS) because it introduces a unique, wrap-around approach specifically tailored for adolescents with opioid use disorder (OUD). Unlike traditional treatments that primarily focus on medication adherence alone, YORS involves both the adolescent patients and their treatment significant others (TSOs), enhancing support and engagement throughout the 26-week intervention. This method aims to improve adherence to medication for opioid use disorder (MOUD) by incorporating assertive outreach, which helps re-engage participants and maintain their commitment to recovery. This comprehensive support system distinguishes YORS from conventional treatment approaches, potentially leading to better long-term outcomes for young individuals battling OUD.

What evidence suggests that the Youth Opioid Recovery Support intervention is effective for opioid use disorder?

Research has shown that the Youth Opioid Recovery Support (YORS) program can help young people consistently take their medication for opioid use disorder (OUD). One study found that participants in the YORS program received more of their medication during outpatient visits at both 12 and 24 weeks compared to those who received standard treatment. This suggests that YORS can improve adherence to treatment, which is crucial for recovery. In this trial, all participants will join the YORS intervention condition, which includes family support and proactive outreach to help teens continue their medication. These methods aim to lower the risk of relapse and improve recovery outcomes for adolescents with OUD. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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/study/NCT04173416

The Youth Opioid Recovery Support (YORS) Intervention The assertive YORS intervention has the potential to improve the real-world effectiveness and public health impact of medication for OUD in this very high-risk, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34016297/

A pilot enhancement of the Youth Opioid Recovery Support ... Results: Participants in YORS compared to H-TAU received more outpatient doses at 12 weeks (1.91 vs. 0.40, p < .001) and 24 weeks (3.76 vs. 0.70, p < .001), had ...

3. 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.

4. 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 ...

5. 80a7ba3d04f8b71aa576-301909dc4570c350a1649a6d39e3ef3b.ssl.cf1.rackcdn.com 80a7ba3d04f8b71aa576-301909dc4570c350a1649a6d39e3ef3b.ssl.cf1.rackcdn.com/2959527-94871-003.pdf

Treatment of OUD in Youth: (YORS) Intervention Improving Outcomes for Youth OUD. Treatment. Youth Opioid Recovery Support (YORS). Page 2. Disclosures. • Kaliamurthy. • None. • Wenzel. • Indivior (medications ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11068080/

Relationship-Oriented Recovery System for Youth (RORSY) This article describes a set of modular clinical interventions designed to enhance treatment and recovery processes for adolescents and young adults with Opioid ...

7. publications.aap.org publications.aap.org/pediatrics/article/156/1/e2024070224/202104/Adolescent-and-Young-Adult-Access-to-Opioid-Use

Adolescent and Young Adult Access to Opioid Use ... Adolescents and young adults (AYAs) with opioid use disorder (OUD) have low rates of treatment engagement and retention.