Recruiting

YORS Intervention

Sponsor:

Potomac Health Foundations

Code:

NCT06774248

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Youth Opioid Recovery Support (YORS)

Study Details

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

Study ID

NCT06774248

Start date

Feb 1, 2025

Status verified date

Nov, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Youth Opioid Recovery Support (YORS)

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.

Interventions

Youth Opioid Recovery Support (YORS)

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

Primary outcome measure

  • Cumulative MOUD exposure [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Kevin Wenzel, PhD

410-233-1400kwenzel@marylandtreatment.org

Marc Fishman, MD

410-233-1400mfishman@marylandtreatment.org

Locations

Maryland Treatment Centers

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

Kevin Wenzel, PhD

410-233-1400kwenzel@marylandtreatment.org

More Information

Sponsor

Potomac Health Foundations

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Potomac Health Foundations on 2025-11-18.