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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Youth Opioid Recovery Support (YORS) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youth Opioid Recovery Support (YORS) | Behavioral | The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to medication adherence in this vulnerable young adult population. The YORS intervention primary components are (as detailed below):
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative MOUD exposure | Cumulative days of exposure to MOUD during study intervention period course of treatment, which is operationalized as the proportion of time on prescribed MOUD at 26-weeks compared to the period of time in the intervention. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and Serious Adverse Events | Adverse Events and Serious Adverse Events will be tabulated and described for severity and relatedness to the intervention. | 26 weeks |
| Acceptability | Quantitative scores and qualitative feedback on Treatment Satisfaction Surveys and Interviews will be summarized and described. |
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Inclusion Criteria for adolescent patients with OUD:
Inclusion criteria for Treatment Significant Other (TS) participants
Exclusion Criteria for adolescent patients with OUD:
Exclusion Criteria for Treatment Significant Other (TSO) Participants:
1. Known to currently be sharing drugs with the adolescent participant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Wenzel, PhD | Contact | 410-233-1400 | 244 | kwenzel@marylandtreatment.org |
| Marc Fishman, MD | Contact | 410-233-1400 | mfishman@marylandtreatment.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Treatment Centers | Recruiting | Baltimore | Maryland | 21229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33303086 | Background | Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24. | |
| 32621368 | Background | Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4. |
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After deidentification, the IPD related to primary and secondary outcomes will be made publicly available as required by NIDA data sharing policies.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to medication adherence in this vulnerable adolescent population. The YORS intervention primary components are (as detailed below):
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|
| 26 weeks |
| Participants Enrolled | Number of participants enrolled in the intervention will be tabulated | 26 weeks |
| Opioid Relapse | Opioid relapse (Y/N) will amalgamate self report and urine drug screen data. Relapse is defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks, positive or missing sample imputed as 5 days of opioid use. | 26 weeks |
| Participants Completed | Proportion of enrolled participants who complete the intervention period (i.e., do not withdraw consent or are otherwise removed from the study prior to the intervention end date. | 26 weeks |
| 38494051 | Background | Fishman M, Wenzel K, Gauthier P, Borodovsky J, Murray O, Subramaniam G, Levy S, Fredyma E, McLeman B, Marsch LA. Engagement, initiation, and retention in medication treatment for opioid use disorder among young adults: A narrative review of challenges and opportunities. J Subst Use Addict Treat. 2024 Nov;166:209352. doi: 10.1016/j.josat.2024.209352. Epub 2024 Mar 16. |
| 34016297 | Background | Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26. |
| 39277321 | Background | Wenzel K, Mallik-Kane K, Anderson K, Fishman M. An Assertive Community Intervention to Engage Youth with Opioid Use Disorder and Their Families. Child Adolesc Psychiatr Clin N Am. 2024 Oct;33(4):709-728. doi: 10.1016/j.chc.2024.02.007. Epub 2024 Apr 6. |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |