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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-21
SponsorPotomac Health Foundations

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

English speaking

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)

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)

Stated willingness to comply with all study procedures and the YORS intervention

Disqualifiers

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)

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Youth Opioid Recovery Support (YORS)

    Behavioral

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Youth Opioid Recovery Support (YORS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Acceptability

Quantitative scores and qualitative feedback on Treatment Satisfaction Surveys and Interviews will be summarized and described.

Time frame
26 weeks
3

Participants Enrolled

Number of participants enrolled in the intervention will be tabulated

Time frame
26 weeks
4

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

Other outcomes

Sponsors and contacts

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