NCT04015115: YORS

Youth Opioid Recovery Support: Improving Care Systems

Completed NA Last updated 7 February 2022

What this trial tests

NA trial testing Youth Opioid Recovery Support service model in Opioid-Related Disorders in 44 participants. Completed in 31 October 2020.

Timeline

26 July 2019

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	26 July 2019
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Youth Opioid Recovery Support service model

Conditions studied

• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 26, any sex, with Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment.

Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse.

MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families.

The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment.

This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.