Clinical trial NCT04173416: The Youth Opioid Recovery Support (YORS) Intervention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Medication Adherence
Lead sponsor: Potomac Health Foundations
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Friends Research Institute, Inc.
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-28
* OUD diagnosis
* Willing (intending) to receive treatment with XR-NTX or XR-BUP under the care of a MTC physician/nurse practitioner
* Willingness to designate family member (or other suitable treatment significant other) for treatment involvement (i.e., a treatment significant other; TSO)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of MOUD injections received (XR-NTX or XR-BUP)
timeFrame: Treatment week 0 to 26 weeks
measure: Rate of opioid relapse during the study period
timeFrame: Time Frame: Data measured every 2 weeks for the duration of the 26-week study period
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center
state: Maryland
Study officials:
affiliation: Maryland Treatment Centers
name: Marc Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References: