Expanding the Youth Opioid Recovery Support (YORS) Intervention for MOUD Adherence to Adolescents With OUD

Potomac Health Foundations

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Behavioral: Youth Opioid Recovery Support (YORS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06774248

1R34DA062260-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Adolescents with OUD are a critical but underserved population. 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). Estimates of timely MOUD initiation among adolescents with OUD are ≤ 5% and only a quarter of residential addiction treatment facilities for adolescents even offer buprenorphine. Among the few adolescents with OUD who do receive MOUD, adherence is alarmingly low.

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. This project will expand the investigation of the YORS intervention, with demonstrated efficacy in young adults, to the critical underserved population of adolescents with OUD. Adolescents are theoretically even more likely than young adults to respond to YORS components such as family involvement, persuasion, and leverage because of their developmentally normative greater reliance on parental guidance and influence. Through this project investigators also will expand the YORS intervention to include adolescents choosing sublingual buprenorphine, which are adaptations responsive to our local clinical experience and national trends.

To achieve these aims, investigators will test the feasibility and pilot impact of YORS for N=40 adolescents and their family members in an uncontrolled, single arm clinical trial in preparation for a future larger scale randomized controlled trial. Because the preferred MOUD for adolescents in our clinical experience has been daily sublingual buprenorphine (rather than XR-MOUD), investigators will adapt YORS for sublingual buprenorphine. Finally, investigators will also conduct qualitative interviews to better understand the experience of adolescents with OUD and their families.

Enrollment: 80 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for adolescent patients with OUD:

1. English speaking
2. 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)
3. Willing to have a legal, English-speaking guardian provide informed consent (may be collected verbally over audio and/or video platform in the event of a remote enrollment)
4. Stated willingness to comply with all study procedures and the YORS intervention
5. Age 13-21 (inclusive)
6. Documented diagnosis of opioid use disorder (OUD)
7. Presenting for an index episode of inpatient or outpatient treatment at Maryland Treatment Centers with at least one day of opioid use in the 30 days prior to enrollment
8. Considering treatment with XR-NTX, XR-BUP, or SL-BUP* OR has begun SL-BUP maintenance treatment within the past two weeks
9. Willing to designate a parent, family member, or other person to be involved in their OUD treatment as a Treatment Significant Other
10. Access to a mobile phone

Inclusion criteria for Treatment Significant Other (TS) participants

1. English speaking
2. Provision of signed and dated informed consent form (may be collected verbally over audio and/or video platform in the event of a remote enrollment)
3. Stated willingness to comply with all study procedures and the YORS intervention
4. Parent, legal guardian, or other treatment support person designated by an adolescent patient participant to be involved in their OUD treatment as a Treatment Significant Other
5. Age 18 years or older
6. Access to a mobile phone

Exclusion Criteria for adolescent patients with OUD:

1. Psychiatric or medical instability that, in the opinion of the PI, would preclude participation in the trial (e.g., suicidality, psychosis, Sickle Cell disease with frequent crises)
2. Living situation that, in the opinion of the PI, would preclude participation in the trial (e.g., location greater than 75 miles from the treatment center, homelessness)

Exclusion Criteria for Treatment Significant Other (TSO) Participants:

1. Known to currently be sharing drugs with the adolescent participant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Youth Opioid Recovery Support (YORS)

Experimental group

Description:

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.

Treatment:

Behavioral: Youth Opioid Recovery Support (YORS)