<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03306368</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00144092</org_study_id>
    <nct_id>NCT03306368</nct_id>
  </id_info>
  <brief_title>Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone</brief_title>
  <acronym>YORS</acronym>
  <official_title>Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Potomac Health Foundations</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Potomac Health Foundations</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioid addiction among youth (including both adolescents and young adults) is a growing&#xD;
      health problem with catastrophic consequences for young people and their families. The&#xD;
      current opioid epidemic disproportionately affects youth. Furthermore, compared to adults,&#xD;
      adolescents and young adults tend to have poorer engagement in and response to treatment than&#xD;
      older adults. Relapse prevention medications are the clear standard of care for the treatment&#xD;
      of opioid addiction in adults, but the evidence base for effectiveness including&#xD;
      implementation is not well-established in youth, and concerns from the field emphasize poor&#xD;
      adherence and retention. Further there is no consensus regarding models of care, psychosocial&#xD;
      treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX)&#xD;
      has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the&#xD;
      field needs further clarification of its optimal use and delivery in this target population,&#xD;
      in the context of developmentally informed models of care. There is inadequate current&#xD;
      capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse&#xD;
      prevention medication) with psychosocial treatment in a context that is youth welcoming and&#xD;
      family empowering.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While retention in youth opioid treatment has generally been poor, assertive outreach has not&#xD;
      been standard. There may be models from other populations with elements worth considering,&#xD;
      such as Assertive Community Treatment (ACT) for severe and persistent mental illness or&#xD;
      Assertive Continuing Care (ACC) for adolescents with cannabis use disorders. These are&#xD;
      programs providing wrap-around services that include home-based services and medication&#xD;
      administration visits, assertive outreach, intense case management, family engagement in&#xD;
      order to address engagement barriers. ACC has considerable developmental validity, has been&#xD;
      used widely and been scaled by SAMHSA in broad implementations for youth SUDs (other than&#xD;
      OUD). ACT has become a broad standard of care for adults with chronic severe mental illness&#xD;
      such as schizophrenia, who struggle with non-adherence and poor outcomes in conventional&#xD;
      treatment. ACT also typically includes a medication home-delivery component. Most states have&#xD;
      also developed standard public sector reimbursement models for ACT. But very little work has&#xD;
      been done to adapt or adopt these models to the population of youth with opioid addiction.&#xD;
&#xD;
      Furthermore, limitations on adherence to XR-NTX under non-research conditions have been a&#xD;
      barrier to optimal effectiveness. One study reported that among 62 adult patients completing&#xD;
      inpatient detoxification who received an XR-NTX prior to discharge, 55% returned for a second&#xD;
      injection and 16% received a third injection. In the LA County evaluation, only 17% of the&#xD;
      171 adults who received an XR-NTX injection received their third injection. The&#xD;
      investigators' first case series of 16 youth receiving XR-NTX for opioid addiction, the&#xD;
      average total number of outpatient doses received within 4 months of outpatient treatment was&#xD;
      1.5, corresponding to 38% of the potential 4 monthly doses, with 25% dropping out before&#xD;
      receiving any outpatient doses. A naturalistic study published by the investigators, of young&#xD;
      adult opioid treatment with either buprenorphine or XR-NTX and high intensity psychosocial&#xD;
      treatment support included 13 cases treated with XR-NTX. This cohort had 40% retention at 6&#xD;
      months, no difference between the buprenorphine and XR-NTX groups, with an average number of&#xD;
      3.1 outpatient doses received within 6 months, corresponding to 52% of the potential 6&#xD;
      monthly doses. And while 54% received a 3rd outpatient dose, this was a low-volume program&#xD;
      that selected highly motivated patients willing to accept the requirements and burdens of&#xD;
      frequent attendance and intensive structure, and included only those who had initiated&#xD;
      outpatient treatment following inpatient treatment.&#xD;
&#xD;
      To address these gaps discussed above, the investigators propose N=45 (~5 pilot intervention&#xD;
      cases prior to randomization; see protocol) participants with OUD to be randomized to&#xD;
      treatment as usual (TAU) or YORs intervention, which incorporates XR-NTX into a&#xD;
      developmentally informed, multi-component model of care - Youth Opioid Recovery Support&#xD;
      (YORS; see protocol for additional detail on the intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of weeks retained in treatment</measure>
    <time_frame>Treatment week 1 to 24 weeks</time_frame>
    <description># of weeks participant remains in treatment after discharge from inpatient care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of weeks negative for opioid use</measure>
    <time_frame>Treatment week 1 to 24 weeks</time_frame>
    <description>Number of weeks participant tests negative for opiates and reports no use of opiates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who linked to after care</measure>
    <time_frame>Treatment week 0 to treatment week 4</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of XR-NTX doses received</measure>
    <time_frame>Treatment week 1 to 24 weeks</time_frame>
    <description>Total number of XR-NTX doses received within 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of weeks negative for substances other than opiates</measure>
    <time_frame>Treatment week 1 to 24 weeks</time_frame>
    <description>Number of weeks participant tests negative for substances other than opiates and reports no use of other illicit substances.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Opioid-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Youth Opioid Recovery Support (YORS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Youth Opioid Recovery Support consists of the following component:&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Youth Opioid Recovery Support</intervention_name>
    <description>The components of the Youth Opioid Recovery Support intervention are:&#xD;
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.</description>
    <arm_group_label>Youth Opioid Recovery Support (YORS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young adults age 18-26 with OUD who present for an index episode of&#xD;
             residential/inpatient opioid detoxification and seek treatment with XR-NTX at Mountain&#xD;
             Manor Treatment Center (MMTC).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver function tests (LFTs) &gt; 5x upper limit of normal&#xD;
&#xD;
          -  Psychiatric or medical instability (eg suicidailty, psychosis, Sickle Cell disease&#xD;
             with frequent crises, etc) that would preclude participation in the trial&#xD;
&#xD;
          -  Living situation (location greater than 60 miles from the center, homelessness) that&#xD;
             would preclude participation in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc J Fishman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mountain Manor Treatment Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Fishman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Potomac Health Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mountain Manor Treatment Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26820059</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28867062</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20626723</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>33303086</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>34016297</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>32621368</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OUD</keyword>
  <keyword>XR-NTX</keyword>
  <keyword>assertive outreach</keyword>
  <keyword>youth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306368
org study id: IRB00144092
nct id: NCT03306368
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of weeks retained in treatment
time frame: Treatment week 1 to 24 weeks
description: # of weeks participant remains in treatment after discharge from inpatient care
measure: Number of weeks negative for opioid use
time frame: Treatment week 1 to 24 weeks
description: Number of weeks participant tests negative for opiates and reports no use of opiates.
measure: Number of patients who linked to after care
time frame: Treatment week 0 to treatment week 4
description: 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.
measure: Number of XR-NTX doses received
time frame: Treatment week 1 to 24 weeks
description: Total number of XR-NTX doses received within 24 weeks
measure: Number of weeks negative for substances other than opiates
time frame: Treatment week 1 to 24 weeks
description: Number of weeks participant tests negative for substances other than opiates and reports no use of other illicit substances.
arm group label: Treatment as Usual (TAU)
arm group type: No Intervention
description: Participants receiving treatment as usual post-residential detox. TAU clinic-based treatment receiving standard clinic-based XR-NTX.
arm group label: Youth Opioid Recovery Support (YORS)
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Youth Opioid Recovery Support
description: 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.
arm group label: Youth Opioid Recovery Support (YORS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: No
last name: Marc J Fishman, MD
role: Principal Investigator
affiliation: Mountain Manor Treatment Center
last name: Marc Fishman, MD
role: Principal Investigator
affiliation: Potomac Health Foundation
facility: 
country: United States
citation: 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: 26820059
citation: 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: 28867062
citation: 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: 20626723
citation: 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: 33303086
citation: 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: 34016297
citation: 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: 32621368
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Analgesics, Opioid
sharing ipd: Undecided