Youth Opioid Recovery Support: Improving Care Systems

NCT04015115 | Completed

• 1 other identifier: HP-0085682
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (1)

Youth Opioid Recovery Support service model

EXPERIMENTAL

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

Interventions

Youth Opioid Recovery Support service model BEHAVIORAL

see arm 1 description

Youth Opioid Recovery Support service model

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Mountain Manor Treatment Center

Baltimore, Maryland, 21229, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chemically-Induced Disorders; Heroin Dependence; Medication Adherence; Mental Disorders; Patient Compliance

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marc Fishman, MD

  Mountain Manor Treatment Center

  PRINCIPAL INVESTIGATOR

• Kevin Wenzel, PhD

  Mountain Manor Treatment Center

  STUDY DIRECTOR

• Victoria Selby, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: July 26, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)