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

NCT06774248 | Recruiting DMC

• 1 other identifier: 1R34DA062260-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

adolescents; addiction; concerned significant other; family therapy; Medications for opioid use disorder; medication adherence; buprenorphine; naltrexone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Adverse Events and Serious Adverse Events

  26 weeks

• Acceptability

  26 weeks

• Participants Enrolled

  26 weeks

• Opioid Relapse

  26 weeks

• Participants Completed

  26 weeks

Study Arms (1)

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.

Behavioral: Youth Opioid Recovery Support (YORS)

Interventions

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): 1. Low barrier access to MOUD, including home delivery, ride-share app transportation and mobile van delivery and low barrier access to MOUD in general 2. Engagement of families in collaborative treatment planning and monitoring with a focus on medication adherence 3. Assertive continuing care: actively tracking and communicating with youth and families by text and social media to promote engagement and adherence 4. Contingency management: to provide incentives for medication adherence

Youth Opioid Recovery Support (YORS)

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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)
• Stated willingness to comply with all study procedures and the YORS intervention
• Age 13-21 (inclusive)
• Documented diagnosis of opioid use disorder (OUD)
• 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
• Considering treatment with XR-NTX, XR-BUP, or SL-BUP\* OR has begun SL-BUP maintenance treatment within the past two weeks
• Willing to designate a parent, family member, or other person to be involved in their OUD treatment as a Treatment Significant Other
• Access to a mobile phone
• English speaking
• 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)
• Stated willingness to comply with all study procedures and the YORS intervention
• 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
• Age 18 years or older

You may not qualify if:

• 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)
• 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)
• \. Known to currently be sharing drugs with the adolescent participant

Sponsors & Collaborators

• Potomac Health Foundations: lead

Study Sites (1)

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 33303086 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.

  PMID: 32621368 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.

  PMID: 38494051 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.

  PMID: 34016297 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.

  PMID: 39277321 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive; Medication Adherence

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Kevin Wenzel, PhD

CONTACT

410-233-1400; kwenzel@marylandtreatment.org

Marc Fishman, MD

CONTACT

410-233-1400; mfishman@marylandtreatment.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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): 1. Low barrier access to MOUD, including home delivery, ride-share app transportation and mobile van delivery and low barrier access to MOUD in general 2. Engagement of families in collaborative treatment planning and monitoring with a focus on medication adherence 3. Assertive continuing care: actively tracking and communicating with youth and families by text and social media to promote engagement and adherence 4. Contingency management: to provide incentives for medication adherence

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)