NCT03306368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

October 2, 2017

Last Update Submit

September 16, 2021

Conditions

Opioid-Related Disorders

Keywords

OUDXR-NTXassertive outreachyouth

Outcome Measures

Primary Outcomes (2)

  • Number of weeks retained in treatment

    \# of weeks participant remains in treatment after discharge from inpatient care

    Treatment week 1 to 24 weeks

  • Number of weeks negative for opioid use

    Number of weeks participant tests negative for opiates and reports no use of opiates.

    Treatment week 1 to 24 weeks

Secondary Outcomes (3)

  • Number of patients who linked to after care

    Treatment week 0 to treatment week 4

  • Number of XR-NTX doses received

    Treatment week 1 to 24 weeks

  • Number of weeks negative for substances other than opiates

    Treatment week 1 to 24 weeks

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX.

Youth Opioid Recovery Support (YORS)

EXPERIMENTAL

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

Interventions

Youth Opioid Recovery SupportBEHAVIORAL

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.

Youth Opioid Recovery Support (YORS)

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain Manor Treatment Center

Baltimore, Maryland, 21229, United States

Location

Related Publications (6)

  • Vo HT, Robbins E, Westwood M, Lezama D, Fishman M. Relapse prevention medications in community treatment for young adults with opioid addiction. Subst Abus. 2016 Jul-Sep;37(3):392-397. doi: 10.1080/08897077.2016.1143435. Epub 2016 Jan 28.

    PMID: 26820059BACKGROUND

  • Vo HT, Burgower R, Rozenberg I, Fishman M. Home-based delivery of XR-NTX in youth with opioid addiction. J Subst Abuse Treat. 2018 Feb;85:84-89. doi: 10.1016/j.jsat.2017.08.007. Epub 2017 Aug 31.

    PMID: 28867062BACKGROUND

  • Fishman MJ, Winstanley EL, Curran E, Garrett S, Subramaniam G. Treatment of opioid dependence in adolescents and young adults with extended release naltrexone: preliminary case-series and feasibility. Addiction. 2010 Sep;105(9):1669-76. doi: 10.1111/j.1360-0443.2010.03015.x. Epub 2010 Jul 9.

    PMID: 20626723BACKGROUND

  • Wenzel K, Fishman M. Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency. J Subst Abuse Treat. 2021 Jan;120:108149. doi: 10.1016/j.jsat.2020.108149. Epub 2020 Sep 24.

    PMID: 33303086BACKGROUND

  • Wenzel K, Selby V, Wildberger J, Lavorato L, Thomas J, Fishman M. Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention. J Subst Abuse Treat. 2021 Jun;125:108306. doi: 10.1016/j.jsat.2021.108306. Epub 2021 Jan 26.

    PMID: 34016297BACKGROUND

  • Fishman M, Wenzel K, Vo H, Wildberger J, Burgower R. A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder. Addiction. 2021 Mar;116(3):548-557. doi: 10.1111/add.15181. Epub 2020 Aug 4.

    PMID: 32621368RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marc J Fishman, MD

    Mountain Manor Treatment Center

    PRINCIPAL INVESTIGATOR

  • Marc Fishman, MD

    Potomac Health Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 11, 2017

Study Start

February 1, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

US(1)