Youth Opioid Recovery Support: Improving Care Systems

Opioid-Related Disorders Clinical Trial

— YORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015115
• Other study ID #: HP-0085682
• Status: Completed
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Behavioral:
• Youth Opioid Recovery Support service model
see arm 1 description

Locations

Country	Name	City	State
United States	Mountain Manor Treatment Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in medication-assisted treatment of opioid use disorder	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	Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
Primary	Opioid relapse	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.	Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
Primary	Total number of opioid positive drug screens	Urine drug screening will objectively determine opioid use or nonuse.	Every 2 weeks for the duration of enrollment, up to 36 weeks.
Secondary	Change in behaviors related to recovery	Participant-reported behaviors associated with function (e.g., employment), legal involvement, HIV risk behavior, overdoses, and crisis utilization (emergency room visit, hospitalization, detoxification services).	Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
Secondary	Continued receipt of care post-intervention	Receipt of medication-assisted treatment at the treatment center after the last dose of home-delivered medication.	Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.