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Clinical Trials/NCT06774248
NCT06774248
Recruiting
Not Applicable

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

Potomac Health Foundations1 site in 1 country80 target enrollmentFebruary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Potomac Health Foundations
Enrollment
80
Locations
1
Primary Endpoint
Cumulative MOUD exposure
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2025
End Date
August 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Potomac Health Foundations
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cumulative MOUD exposure

Time Frame: 26 weeks

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.

Secondary Outcomes

  • Adverse Events and Serious Adverse Events(26 weeks)
  • Acceptability(26 weeks)
  • Participants Enrolled(26 weeks)
  • Opioid Relapse(26 weeks)
  • Participants Completed(26 weeks)

Study Sites (1)

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