NCT06774248 Expanding the Youth Opioid Recovery Support (YORS) Intervention for MOUD Adherence to Adolescents With OUD
| NCT ID | NCT06774248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Potomac Health Foundations |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-02-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06774248 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 21 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774248 currently recruiting?
Yes, NCT06774248 is actively recruiting participants. Contact the research team at kwenzel@marylandtreatment.org for enrollment information.
Where is the NCT06774248 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06774248 clinical trial?
NCT06774248 is sponsored by Potomac Health Foundations. The trial plans to enroll 80 participants.