Maryland Treatment Centers
Baltimore, Maryland, 21229, United States
Location status: Recruiting
NCT Number: NCT06774248
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.
Interested in participating?
Request Info13 year–21 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21229, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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):
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.
Time frame: 26 weeks
Adverse Events and Serious Adverse Events will be tabulated and described for severity and relatedness to the intervention.
Time frame: 26 weeks
Quantitative scores and qualitative feedback on Treatment Satisfaction Surveys and Interviews will be summarized and described.
Time frame: 26 weeks
Number of participants enrolled in the intervention will be tabulated
Time frame: 26 weeks
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
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.
Contact information is provided by the study sponsor or research team.
Potomac Health Foundations
Other
Acronym: YORS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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