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The Youth Opioid Recovery Support (YORS) Intervention (YORS)

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ClinicalTrials.gov Identifier: NCT04173416
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Friends Research Institute, Inc.
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Potomac Health Foundations

Brief Summary:
Youth are disproportionately affected by the current opioid crisis with catastrophic consequences, and young adults with opioid use disorder (OUD) often struggle with adherence to relapse prevention medications. The Youth Opioid Recovery Support (YORS) model is a promising, innovative, wrap-around approach that addresses barriers to medication adherence and treatment engagement in an effort to improve public health outcomes in this vulnerable young adult population. This study seeks to refine the YORS intervention through stakeholder input and pilot iterative testing followed by an efficacy randomized controlled trial. This project will significantly contribute to our knowledge base of practical strategies to address the opioid crisis.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Medication Adherence Behavioral: Youth Opioid Recovery Support (YORS) Not Applicable

Detailed Description:

Young people are disproportionately affected by the current opioid crisis including worse retention and outcomes compared to older adults. Further, young adults typically do not have access to medications for opioid use disorder (OUD), and for those that do, struggles with adherence are a major barrier. Standard approaches to treatment typically do not incorporate developmentally informed strategies for engagement, retention, and medication adherence for this special population.

The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence. YORS is currently showing very promising results in a small pilot randomized clinical trial (RCT) by the investigative team.

The investigators propose to refine and then conduct a more definitive test of the YORS intervention for youth with OUD. In the first phase the investigators will conduct stakeholder focus groups to get input and feedback on potential refinements, while also conducting 3 cycles of pilot testing of these potential refinements. Based on the preparation and final synthesis of the intervention refinements, in the second phase the investigators will conduct an RCT to test the efficacy of YORS, by randomizing N=120 young adults ages 18-26 seeking treatment for OUD with XR-NTX at Mountain Manor Treatment Center (MMTC), to either the refined YORS intervention or treatment as usual (TAU) for a 6-month course of treatment with XR-NTX.

The primary outcome will be number of XR-NTX doses received. Secondary outcomes will include opioid relapse, days of opioid use, time to first opioid relapse, HIV risk behaviors, criminal behaviors, psychiatric symptoms, and family member distress and self-efficacy. It is hypothesized that participants in the YORS condition will receive significantly more XR-NTX doses and will demonstrate less severe opioid use and associated behaviors compared to those in the TAU group. The assertive YORS intervention has the potential to improve the real-world effectiveness and public health impact of medication for OUD in this very high-risk, vulnerable population. If the refined YORS intervention is found to be efficacious, it would set the stage for future work including: an economic analysis, a larger multi-site study, longer intervention duration, study of extended release buprenorphine, and study of step-down to less intensive interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 of the study (years 1-2) will include a single group, open-label, intervention only arm. After iterative cycles of testing and refinement, we will proceed with a parallel group RCT in Phase 2 of the study (years 3-5).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Youth Opioid Recovery Support (YORS) Intervention: An Assertive Community Treatment Model for Improving Medication Adherence in Young Adults With Opioid Use Disorder
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: Youth Opioid Recovery Support (YORS)

The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence.

The specific components of YORS will be refined and adapted based on feedback from interviews and focus groups with various stakeholders. However, the basic framework outlined above is expected to persists.

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 treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence.




Primary Outcome Measures :
  1. Number of XR-NTX doses received [ Time Frame: Treatment week 1 to 12 weeks ]
    Total number of XR-NTX doses received within 12 weeks

  2. Rate of opioid relapse during the study period [ Time Frame: Time Frame: Data measured every 2 weeks for the duration of the 12-week study period ]
    Relapse = 10 days of use within a 28 day period. Days of opioid use will be assessed through urine toxicology and self report methods.



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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-26
  • OUD diagnosis, presenting for an index episode of treatment at MMTC
  • Seeking treatment with XR-NTX
  • Willingness to designate family member (or other suitable treatment significant other) for treatment involvement (i.e., a treatment significant other; TSO)

Exclusion Criteria:

  • Liver function tests (LFTs) > 6x upper limit of normal
  • Psychiatric or medical instability (e.g., suicidality, psychosis, Sickle Cell disease with frequent crises) that would preclude participation in the trial
  • Living situation (location greater than 75 miles from the center, homelessness) that would preclude participation in the trial
  • If female, pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173416


Contacts
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Contact: Marc Fishman, MD 410-233-1400 mjfishman@comcast.net
Contact: Kevin Wenzel, PhD 410-233-1400 kwenzel@mountainmanor.org

Locations
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United States, Maryland
Mountain Manor Treatment Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Kevin Wenzel, PhD    410-233-1400 ext 261    kwenzel@mountainmanor.org   
Contact: Marc Fishman, MD    4102331400 ext 130    mfishman@marylandtreatment.org   
Sponsors and Collaborators
Potomac Health Foundations
National Institutes of Health (NIH)
Friends Research Institute, Inc.
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Marc Fishman, MD Maryland Treatment Centers
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Responsible Party: Potomac Health Foundations
ClinicalTrials.gov Identifier: NCT04173416    
Other Study ID Numbers: R61AT010614 ( U.S. NIH Grant/Contract )
R61AT010614 ( U.S. NIH Grant/Contract )
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents