The Youth Opioid Recovery Support (YORS) Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-28
SponsorPotomac Health Foundations
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Youth Opioid Recovery Support (YORS)
BehavioralThe 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Youth Opioid Recovery Support (YORS)Experimental treatment 1 intervention
Group B: Treatment As UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of MOUD injections received (XR-NTX or XR-BUP)
Total number of injections received within 26 weeks
Time frame
Treatment week 0 to 26 weeks2
Rate of opioid relapse during the 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.
Time frame
Time Frame: Data measured every 2 weeks for the duration of the 26-week study periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Potomac Health Foundations
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Friends Research Institute, Inc.
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov