YORS: Youth Opioid Recovery Support: Improving Care Systems

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT04015115

Collaborator

(none)

Enrollment

Location

Arm

15.2

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Related Disorders	Behavioral: Youth Opioid Recovery Support service model	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder

Actual Study Start Date :

Jul 26, 2019

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Youth Opioid Recovery Support service model The components of the Youth Opioid Recovery Support service model includes 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 medication treatment.	Behavioral: Youth Opioid Recovery Support service model see arm 1 description

Arm

Intervention/Treatment

Experimental: Youth Opioid Recovery Support service model

The components of the Youth Opioid Recovery Support service model includes 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 medication treatment.

Behavioral: Youth Opioid Recovery Support service model

see arm 1 description

Outcome Measures

Primary Outcome Measures

Retention in medication-assisted treatment of opioid use disorder [Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.]
Total number of outpatient doses of extended-release naltrexone or extended-release buprenorphine received by the participant between enrollment and the end of the study window
Opioid relapse [Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.]
Opioid Relapse is defined as 10 days of opioid use within a 28-day period. Days of opioid use are calculated using data from self report and urine toxicology with missing or positive urine specimens imputed as 5 days of use.
Total number of opioid positive drug screens [Every 2 weeks for the duration of enrollment, up to 36 weeks.]
Urine drug screening will objectively determine opioid use or nonuse.

Secondary Outcome Measures

Change in behaviors related to recovery [Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.]
Participant-reported behaviors associated with function (e.g., employment), legal involvement, HIV risk behavior, overdoses, and crisis utilization (emergency room visit, hospitalization, detoxification services).
Continued receipt of care post-intervention [Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.]
Receipt of medication-assisted treatment at the treatment center after the last dose of home-delivered medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 26 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Young adults, ages 18-26, admitted to residential/inpatient addiction treatment
Meets DSM-5 criteria for opioid use disorder
Has used opioids other than specifically prescribed within 30 days prior to consent
Has selected treatment with extended-release naltrexone or extended-release buprenorphine
Is prescribed extended-release naltrexone or extended-release buprenorphine under the care of a Mountain Manor Treatment Center physician or nurse practitioner
Willing to designate one or more family members of their choice to be involved with their treatment.
Family Participant: must be at least 18 years old, be designated by the patient Participant, and willing to be involved in the treatment.

Exclusion Criteria:

Living situation is beyond a reasonable travel distance from the treatment center
Currently, in jail, prison, or any inpatient overnight facility as required by course of law or have a pending legal action which may prevent an individual from completing the study