Opioid Use DisorderYORSNCT06774248
Expanding the Youth Opioid Recovery Support (YORS) Intervention for MOUD Adherence to Adolescents With OUD
A study testing Youth Opioid Recovery Support (YORS) in people with Opioid Use Disorder, run by Potomac Health Foundations at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Youth Opioid Recovery Support (YORS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Age 13-21 (inclusive)
- Documented diagnosis of opioid use disorder (OUD)
Show all 17Show fewer
- 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
- Considering treatment with XR-NTX, XR-BUP, or SL-BUP* OR has begun SL-BUP maintenance treatment within the past two weeks
- Willing to designate a parent, family member, or other person to be involved in their OUD treatment as a Treatment Significant Other
- Access to a mobile phone
- Inclusion criteria for Treatment Significant Other (TS) participants
- English speaking
- 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)
- Stated willingness to comply with all study procedures and the YORS intervention
- 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
- Age 18 years or older
- Access to a mobile phone
Who cannot join
- 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)
- Exclusion Criteria for Treatment Significant Other (TSO) Participants:
- 1. Known to currently be sharing drugs with the adolescent participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maryland Treatment Centers
Baltimore, Maryland, 21229
Kevin Wenzel, PhD, 410-233-1400, kwenzel@marylandtreatment.org
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Youth Opioid Recovery Support (YORS)
- Keywords
- adolescents, addiction, concerned significant other, family therapy, Medications for opioid use disorder, medication adherence, buprenorphine, naltrexone
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Opioid Recovery Support (YORS)Behavioural
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):
- Low barrier access to MOUD, including home delivery, ride-share app transportation and mobile van delivery and low barrier access to MOUD in general
- Engagement of families in collaborative treatment planning and monitoring with a focus on medication adherence
- Assertive continuing care: actively tracking and communicating with youth and families by text and social media to promote engagement and adherence
- Contingency management: to provide incentives for medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Youth Opioid Recovery Support (YORS) | Experimental | 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. Receives: Behavioral: Youth Opioid Recovery Support (YORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (5)
Adverse Events and Serious Adverse Events
Adverse Events and Serious Adverse Events will be tabulated and described for severity and relatedness to the intervention.
Measured: 26 weeks
Acceptability
Quantitative scores and qualitative feedback on Treatment Satisfaction Surveys and Interviews will be summarized and described.
Measured: 26 weeks
Participants Enrolled
Number of participants enrolled in the intervention will be tabulated
Measured: 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.
Measured: 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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to medication adherence in this vulnerable adolescent 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774248
- Sponsor's protocol ID
- 1R34DA062260-01
- Acronym
- YORS
- Status last verified
- Nov 2025
- First submitted
- 8 Jan 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After deidentification, the IPD related to primary and secondary outcomes will be made publicly available as required by NIDA data sharing policies.
Publications
Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.
PubMed 33303086Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4.
PubMed 32621368Fishman M, Wenzel K, Gauthier P, Borodovsky J, Murray O, Subramaniam G, Levy S, Fredyma E, McLeman B, Marsch LA. Engagement, initiation, and retention in medication treatment for opioid use disorder among young adults: A narrative review of challenges and opportunities. J Subst Use Addict Treat. 2024 Nov;166:209352. doi: 10.1016/j.josat.2024.209352. Epub 2024 Mar 16.
PubMed 38494051Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.
PubMed 34016297Wenzel K, Mallik-Kane K, Anderson K, Fishman M. An Assertive Community Intervention to Engage Youth with Opioid Use Disorder and Their Families. Child Adolesc Psychiatr Clin N Am. 2024 Oct;33(4):709-728. doi: 10.1016/j.chc.2024.02.007. Epub 2024 Apr 6.
PubMed 39277321
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Youth Opioid Recovery Support (YORS) Intervention for MOUD Adherence to Adolescents With OUD
- ClinicalTrials.gov ID
- NCT06774248
- Acronym / sponsor ID
- YORS / 1R34DA062260-01
- Conditions
- Opioid Use Disorder
- Keywords
- adolescents, addiction, concerned significant other, family therapy, Medications for opioid use disorder, medication adherence, buprenorphine, naltrexone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to medication adherence in this vulnerable adolescent 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
| Arm | Type | Receives |
|---|---|---|
| Youth Opioid Recovery Support (YORS) | Experimental | Behavioral: Youth Opioid Recovery Support (YORS)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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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
- Age 13-21 (inclusive)
Key exclusion criteria (4 listed)
- 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)
- 1. Known to currently be sharing drugs with the adolescent participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Youth Opioid Recovery Support (YORS) |
Primary outcome
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.
5 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: 26 weeks
Acceptability
Time frame: 26 weeks
Participants Enrolled
Time frame: 26 weeks
Opioid Relapse
Time frame: 26 weeks
Participants Completed
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 33303086Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.
- Background: PubMed 32621368Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4.
- Background: PubMed 38494051Fishman M, Wenzel K, Gauthier P, Borodovsky J, Murray O, Subramaniam G, Levy S, Fredyma E, McLeman B, Marsch LA. Engagement, initiation, and retention in medication treatment for opioid use disorder among young adults: A narrative review of challenges and opportunities. J Subst Use Addict Treat. 2024 Nov;166:209352. doi: 10.1016/j.josat.2024.209352. Epub 2024 Mar 16.
- Background: PubMed 34016297Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.
- Background: PubMed 39277321Wenzel K, Mallik-Kane K, Anderson K, Fishman M. An Assertive Community Intervention to Engage Youth with Opioid Use Disorder and Their Families. Child Adolesc Psychiatr Clin N Am. 2024 Oct;33(4):709-728. doi: 10.1016/j.chc.2024.02.007. Epub 2024 Apr 6.
- Individual participant dataSharing planned: Yes. After deidentification, the IPD related to primary and secondary outcomes will be made publicly available as required by NIDA data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Opioid Recovery Support (YORS) in people with Opioid Use Disorder, run by Potomac Health Foundations at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Wenzel, PhD (410-233-1400 ext. 244, kwenzel@marylandtreatment.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative MOUD exposure (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774248, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.