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Youth Opioid Recovery Support: Improving Care Systems (YORS)

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Youth Opioid Recovery Support service model
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Buprenorphine, Central Nervous System Depressants, Chemically-Induced Disorders, Community Mental Health Services, Drug Partial Agonism, Heroin Dependence, Medication Adherence, Mental Disorders, Naltrexone, Narcotic Antagonists, Narcotics, Opioid-Related Disorders, Opioid Substitution Treatment, Patient Compliance

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mountain Manor Treatment Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Youth Opioid Recovery Support service model

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
Total number of opioid positive drug screens
Urine drug screening will objectively determine opioid use or nonuse.

Secondary Outcome Measures

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).
Continued receipt of care post-intervention
Receipt of medication-assisted treatment at the treatment center after the last dose of home-delivered medication.

Full Information

First Posted
July 1, 2019
Last Updated
January 22, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT04015115
Brief Title
Youth Opioid Recovery Support: Improving Care Systems
Acronym
YORS
Official Title
Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
Buprenorphine, Central Nervous System Depressants, Chemically-Induced Disorders, Community Mental Health Services, Drug Partial Agonism, Heroin Dependence, Medication Adherence, Mental Disorders, Naltrexone, Narcotic Antagonists, Narcotics, Opioid-Related Disorders, Opioid Substitution Treatment, Patient Compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fishman, MD
Organizational Affiliation
Mountain Manor Treatment Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Wenzel, PhD
Organizational Affiliation
Mountain Manor Treatment Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Victoria Selby, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Manor Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Youth Opioid Recovery Support: Improving Care Systems

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