<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/NCT04408313</url>
  </required_header>
  <id_info>
    <org_study_id>1UG1DA050077</org_study_id>
    <nct_id>NCT04408313</nct_id>
  </id_info>
  <brief_title>Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail</brief_title>
  <official_title>A Comparative Effectiveness Trial of Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Friends Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Friends Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with&#xD;
      opioid use disorder in county jails throughout the state of Maryland will be randomly&#xD;
      assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail&#xD;
      followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX&#xD;
      (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a&#xD;
      community treatment program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to&#xD;
      provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will&#xD;
      participate in a randomized controlled trial throughout the state of Maryland, in which 240&#xD;
      incarcerated men and women will be randomly assigned within gender within jail to one of two&#xD;
      arms: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a&#xD;
      treatment program. Arm 2. XR-NTX (n=120). XR-NTX in jail, followed by 6 monthly injections&#xD;
      post-release at a treatment program. In addition to the RCT the investigators will use a&#xD;
      learning collaborative to examine the acceptability and feasibility of medications for opioid&#xD;
      use disorder (MOUDs). Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in&#xD;
      terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received).&#xD;
      Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d)&#xD;
      overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental&#xD;
      health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g)&#xD;
      criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a&#xD;
      learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional&#xD;
      counties that selected not to participate in the randomized trial to understand factors&#xD;
      related to: (a) acceptability of providing long-acting agonists and antagonists in jail&#xD;
      settings; and (b) feasibility of providing medication continuity of care from jail to&#xD;
      community treatment providers. Aim 3. Calculate the cost to the correctional health system of&#xD;
      implementing an XR-B or XR-NTX program, and determine the relative value of each strategy,&#xD;
      including the costs associated with the subsequent interventions in the community, from a&#xD;
      state-policymaker and societal perspective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">January 2, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <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>pharmacotherapy adherence</measure>
    <time_frame>6-months post-release</time_frame>
    <description>number of monthly injections received (0-6)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>illicit opioid urine screening test results</measure>
    <time_frame>1-7,12-months</time_frame>
    <description>number of illicit opioid positive urine drug screen results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-reported illicit opioid use</measure>
    <time_frame>Baseline, 1-7,12-months</time_frame>
    <description>self reported days of illicit opioid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overdose events</measure>
    <time_frame>Baseline, 1-7,12-months</time_frame>
    <description>number of fatal and non-fatal overdoses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System</measure>
    <time_frame>Baseline, 1-7,12-months</time_frame>
    <description>physical, mental, and social health&#xD;
scored 0: Death&#xD;
scored &lt; 1: A state worse than perfect health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk Assessment Battery (RAB)</measure>
    <time_frame>Baseline, 1-7,12-months</time_frame>
    <description>HIV risk behaviors; total score/40 (range=0-1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Criminal activity</measure>
    <time_frame>Baseline, 1-7,12-months</time_frame>
    <description>number of days committed crime (20 crimes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-arrest</measure>
    <time_frame>12-months</time_frame>
    <description>time to rearrest (days to arrest)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-incarceration</measure>
    <time_frame>12-months</time_frame>
    <description>time to re-incarceration (days to re-incarceration)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>XR-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release buprenorphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XR-NTX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Extended-release naltrexone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XR-B</intervention_name>
    <description>Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.</description>
    <arm_group_label>XR-B</arm_group_label>
    <other_name>extended-release buprenorphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XR-NTX</intervention_name>
    <description>Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.</description>
    <arm_group_label>XR-NTX</arm_group_label>
    <other_name>extended-release naltrexone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female inmates at participating jails who are eligible for release&#xD;
             within 120 days&#xD;
&#xD;
          -  History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid&#xD;
             use disorder at the time of incarceration; individuals not meeting the opioid-disorder&#xD;
             criterion will be eligible if they were treated in an opioid agonist treatment program&#xD;
             during the year before incarceration)&#xD;
&#xD;
          -  Suitability for XR-B and/or XR-NTX treatment as determined by medical evaluation&#xD;
&#xD;
          -  Willingness to enroll in XR-B or XR-NTX treatment in jail&#xD;
&#xD;
          -  Planning to live in one of the 7 participating counties and/or surrounding counties&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver function test levels greater than 4 times normal;&#xD;
&#xD;
          -  Active medical illness that may make participation hazardous (e.g., unstable diabetes,&#xD;
             heart disease; moderate to severe renal impairment; adequately treated medical&#xD;
             conditions are acceptable);&#xD;
&#xD;
          -  Conditions or medications that may predispose to QTc prolongation (personal or family&#xD;
             history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g.,&#xD;
             macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and&#xD;
             antidepressant)&#xD;
&#xD;
          -  Untreated psychiatric disorder that may make participation hazardous (e.g., untreated&#xD;
             psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and&#xD;
             appropriate psychotropic medications will be allowed);&#xD;
&#xD;
          -  History of allergic reaction to naltrexone and/or buprenorphine;&#xD;
&#xD;
          -  Current chronic pain diagnosis for which opioids are prescribed;&#xD;
&#xD;
          -  Pregnancy (for women);&#xD;
&#xD;
          -  Breast-feeding (for women);&#xD;
&#xD;
          -  Suicidal ideation (within the past 6 months);&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 40;&#xD;
&#xD;
          -  Inability to pass a study enrollment quiz;&#xD;
&#xD;
          -  Currently enrolled in jail-based MOUD pharmacotherapy (methadone, buprenorphine,&#xD;
             naltrexone)&#xD;
&#xD;
          -  Enrolled in a methadone treatment program in the past 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Gordon, DPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friends Research Institute, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael S Gordon, DPA</last_name>
    <phone>410-837-3977</phone>
    <phone_ext>251</phone_ext>
    <email>mgordon@friendsresearch.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shannon G Mitchell, PhD</last_name>
    <phone>410-837-3977</phone>
    <phone_ext>238</phone_ext>
    <email>smitchell@friendsresearch.olrg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Friends Research Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Gordon</last_name>
      <phone>410-837-3977</phone>
      <email>mgordon@friendsresearch.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Naltrexone</mesh_term>
    <mesh_term>Buprenorphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04408313
org study id: 1UG1DA050077
nct id: NCT04408313
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with
      opioid use disorder in county jails throughout the state of Maryland will be randomly
      assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail
      followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX
      (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a
      community treatment program.
This study is a Type 1 hybrid effectiveness-implementation trial. County jails willing to
      provide extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-B) will
      participate in a randomized controlled trial throughout the state of Maryland, in which 240
      incarcerated men and women will be randomly assigned within gender within jail to one of two
      arms: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a
      treatment program. Arm 2. XR-NTX (n=120). XR-NTX in jail, followed by 6 monthly injections
      post-release at a treatment program. In addition to the RCT the investigators will use a
      learning collaborative to examine the acceptability and feasibility of medications for opioid
      use disorder (MOUDs). Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in
      terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received).
      Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d)
      overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental
      health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g)
      criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a
      learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional
      counties that selected not to participate in the randomized trial to understand factors
      related to: (a) acceptability of providing long-acting agonists and antagonists in jail
      settings; and (b) feasibility of providing medication continuity of care from jail to
      community treatment providers. Aim 3. Calculate the cost to the correctional health system of
      implementing an XR-B or XR-NTX program, and determine the relative value of each strategy,
      including the costs associated with the subsequent interventions in the community, from a
      state-policymaker and societal perspective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pharmacotherapy adherence
time frame: 6-months post-release
description: number of monthly injections received (0-6)
measure: illicit opioid urine screening test results
time frame: 1-7,12-months
description: number of illicit opioid positive urine drug screen results
measure: self-reported illicit opioid use
time frame: Baseline, 1-7,12-months
description: self reported days of illicit opioid use
measure: overdose events
time frame: Baseline, 1-7,12-months
description: number of fatal and non-fatal overdoses
measure: Patient-Reported Outcomes Measurement Information System
time frame: Baseline, 1-7,12-months
description: physical, mental, and social health
scored 0: Death
scored < 1: A state worse than perfect health
measure: Risk Assessment Battery (RAB)
time frame: Baseline, 1-7,12-months
description: HIV risk behaviors; total score/40 (range=0-1)
measure: Criminal activity
time frame: Baseline, 1-7,12-months
description: number of days committed crime (20 crimes)
measure: Re-arrest
time frame: 12-months
description: time to rearrest (days to arrest)
measure: Re-incarceration
time frame: 12-months
description: time to re-incarceration (days to re-incarceration)
arm group label: XR-B
arm group type: Experimental
description: Extended-release buprenorphine
arm group label: XR-NTX
arm group type: Active Comparator
description: Extended-release naltrexone
intervention type: Drug
intervention name: XR-B
description: Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.
arm group label: XR-B
other name: extended-release buprenorphine
intervention type: Drug
intervention name: XR-NTX
description: Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.
arm group label: XR-NTX
other name: extended-release naltrexone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael S Gordon, DPA
role: Principal Investigator
affiliation: Friends Research Institute, Inc.
last name: Michael S Gordon, DPA
phone: 410-837-3977
phone ext: 251
email: mgordon@friendsresearch.org
last name: Shannon G Mitchell, PhD
phone: 410-837-3977
phone ext: 238
email: smitchell@friendsresearch.olrg
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
mesh term: Buprenorphine