Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone (YORS)

September 16, 2021 updated by: Potomac Health Foundations
Opioid addiction among youth (including both adolescents and young adults) is a growing health problem with catastrophic consequences for young people and their families. The current opioid epidemic disproportionately affects youth. Furthermore, compared to adults, adolescents and young adults tend to have poorer engagement in and response to treatment than older adults. Relapse prevention medications are the clear standard of care for the treatment of opioid addiction in adults, but the evidence base for effectiveness including implementation is not well-established in youth, and concerns from the field emphasize poor adherence and retention. Further there is no consensus regarding models of care, psychosocial treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX) has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the field needs further clarification of its optimal use and delivery in this target population, in the context of developmentally informed models of care. There is inadequate current capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse prevention medication) with psychosocial treatment in a context that is youth welcoming and family empowering.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While retention in youth opioid treatment has generally been poor, assertive outreach has not been standard. There may be models from other populations with elements worth considering, such as Assertive Community Treatment (ACT) for severe and persistent mental illness or Assertive Continuing Care (ACC) for adolescents with cannabis use disorders. These are programs providing wrap-around services that include home-based services and medication administration visits, assertive outreach, intense case management, family engagement in order to address engagement barriers. ACC has considerable developmental validity, has been used widely and been scaled by SAMHSA in broad implementations for youth SUDs (other than OUD). ACT has become a broad standard of care for adults with chronic severe mental illness such as schizophrenia, who struggle with non-adherence and poor outcomes in conventional treatment. ACT also typically includes a medication home-delivery component. Most states have also developed standard public sector reimbursement models for ACT. But very little work has been done to adapt or adopt these models to the population of youth with opioid addiction.

Furthermore, limitations on adherence to XR-NTX under non-research conditions have been a barrier to optimal effectiveness. One study reported that among 62 adult patients completing inpatient detoxification who received an XR-NTX prior to discharge, 55% returned for a second injection and 16% received a third injection. In the LA County evaluation, only 17% of the 171 adults who received an XR-NTX injection received their third injection. The investigators' first case series of 16 youth receiving XR-NTX for opioid addiction, the average total number of outpatient doses received within 4 months of outpatient treatment was 1.5, corresponding to 38% of the potential 4 monthly doses, with 25% dropping out before receiving any outpatient doses. A naturalistic study published by the investigators, of young adult opioid treatment with either buprenorphine or XR-NTX and high intensity psychosocial treatment support included 13 cases treated with XR-NTX. This cohort had 40% retention at 6 months, no difference between the buprenorphine and XR-NTX groups, with an average number of 3.1 outpatient doses received within 6 months, corresponding to 52% of the potential 6 monthly doses. And while 54% received a 3rd outpatient dose, this was a low-volume program that selected highly motivated patients willing to accept the requirements and burdens of frequent attendance and intensive structure, and included only those who had initiated outpatient treatment following inpatient treatment.

To address these gaps discussed above, the investigators propose N=45 (~5 pilot intervention cases prior to randomization; see protocol) participants with OUD to be randomized to treatment as usual (TAU) or YORs intervention, which incorporates XR-NTX into a developmentally informed, multi-component model of care - Youth Opioid Recovery Support (YORS; see protocol for additional detail on the intervention).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Mountain Manor Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young adults age 18-26 with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XR-NTX at Mountain Manor Treatment Center (MMTC).

Exclusion Criteria:

  • Liver function tests (LFTs) > 5x upper limit of normal
  • Psychiatric or medical instability (eg suicidailty, psychosis, Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
  • Living situation (location greater than 60 miles from the center, homelessness) that would preclude participation in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Treatment as Usual (TAU)
Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX.
EXPERIMENTAL: Youth Opioid Recovery Support (YORS)

Youth Opioid Recovery Support consists of the following component:

Home delivery of XR-NTX, family framework, assertive continuing care incorporates outreach, home delivery of evidence based psychosocial treatment and case management in a model that specifically targets engagement and motivation in youth, contingency management.
Behavioral: Youth Opioid Recovery Support

The components of the Youth Opioid Recovery Support intervention are:

XR-NTX, home delivery of XR-NTX, the family framework approach engages and empowers families, assertive continuing care incorporates outreach, home delivery of XR-NTX, contingency management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of weeks retained in treatment
Time Frame: Treatment week 1 to 24 weeks
# of weeks participant remains in treatment after discharge from inpatient care
Treatment week 1 to 24 weeks
Number of weeks negative for opioid use
Time Frame: Treatment week 1 to 24 weeks
Number of weeks participant tests negative for opiates and reports no use of opiates.
Treatment week 1 to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who linked to after care
Time Frame: Treatment week 0 to treatment week 4
Percent of patients who successfully link to after care from inpatient to outpatient will be calculated using total number of patients who linked over total number of patients referred.
Treatment week 0 to treatment week 4
Number of XR-NTX doses received
Time Frame: Treatment week 1 to 24 weeks
Total number of XR-NTX doses received within 24 weeks
Treatment week 1 to 24 weeks
Number of weeks negative for substances other than opiates
Time Frame: Treatment week 1 to 24 weeks
Number of weeks participant tests negative for substances other than opiates and reports no use of other illicit substances.
Treatment week 1 to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potomac Health Foundations

Investigators

  • Principal Investigator: Marc J Fishman, MD, Mountain Manor Treatment Center
  • Principal Investigator: Marc Fishman, MD, Potomac Health Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00144092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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