An interventional study of Youth Opioid Recovery Support (YORS) in Opioid Use Disorder, sponsored by Potomac Health Foundations. Recruiting at 1 site in United States. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Potomac Health Foundations · Not applicable, Interventional, and Treatment
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 80 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Potomac Health Foundations is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
Time frame: 26 weeks
Adverse Events and Serious Adverse Events
Adverse Events and Serious Adverse Events will be tabulated and described for severity and relatedness to the intervention.
Time frame: 26 weeks
Acceptability
Quantitative scores and qualitative feedback on Treatment Satisfaction Surveys and Interviews will be summarized and described.
Time frame: 26 weeks
Participants Enrolled
Number of participants enrolled in the intervention will be tabulated
Time frame: 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.
Time frame: 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.
Time frame: 26 weeks
Plan to share: Yes — After deidentification, the IPD related to primary and secondary outcomes will be made publicly available as required by NIDA data sharing policies.
Started Feb 2025 (actual). Primary completion is estimated for Jul 2027, 29 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 29 months is close to that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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