Clinical trial NCT04015115: Youth Opioid Recovery Support: Improving Care Systems
Official title: Youth Opioid Recovery Support (YORS): Improving Care Systems for Young Adults With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Retention in medication-assisted treatment of opioid use disorder
timeFrame: Measured every 4 weeks for the duration of enrollment, up to 36 weeks, by examining participants medical record.
measure: Opioid relapse
timeFrame: Self report and urine specimens will be collected every 2 weeks for the duration of enrollment, up to 36 weeks.
measure: Total number of opioid positive drug screens
timeFrame: Every 2 weeks for the duration of enrollment, up to 36 weeks.
Secondary outcomes:
measure: Change in behaviors related to recovery
timeFrame: Participants will be assessed at baseline (time of enrollment into the study), then, every 4 weeks, up to 36 weeks.
measure: Continued receipt of care post-intervention
timeFrame: Continued care will be assessed at one time-point 1 month following the YORS intervention period of the study.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center
state: Maryland
Study officials:
affiliation: Mountain Manor Treatment Center
name: Marc Fishman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mountain Manor Treatment Center
name: Kevin Wenzel, PhD
role: STUDY_DIRECTOR
affiliation: University of Maryland, Baltimore
name: Victoria Selby, PhD
role: PRINCIPAL_INVESTIGATOR
References: