<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/NCT04464980</url>
  </required_header>
  <id_info>
    <org_study_id>19-01363</org_study_id>
    <secondary_id>CTN-0100</secondary_id>
    <secondary_id>UG1DA013035</secondary_id>
    <secondary_id>UG1DA015831</secondary_id>
    <secondary_id>20-PRS-057</secondary_id>
    <secondary_id>146193</secondary_id>
    <nct_id>NCT04464980</nct_id>
  </id_info>
  <brief_title>Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)</brief_title>
  <official_title>NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      This is a two phase study investigating combinations of pharmacological and behavioral&#xD;
      interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase&#xD;
      will assess strategies for improving retention on buprenorphine (BUP) and extended-release&#xD;
      injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are&#xD;
      most likely to lead to long-term success (absence of relapse), and what characteristics of&#xD;
      participants distinguish those who can safely discontinue Medications for Opioid Use Disorder&#xD;
      (MOUD) from those who remain at risk of relapse and should not discontinue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objectives of this study are:&#xD;
&#xD;
        1. To test strategies to improve retention in treatment on medications for opioid use&#xD;
           disorder (MOUD), among patients initiating treatment for OUD.&#xD;
&#xD;
        2. To test strategies to improve outcomes among patients who have achieved stable remission&#xD;
           on MOUD and want to discontinue MOUD.&#xD;
&#xD;
        3. To develop models to predict who is able to discontinue MOUD without relapse, based on&#xD;
           patient characteristics, including duration of MOUD prior to discontinuation.&#xD;
&#xD;
      The study will have a multicenter, randomized, pragmatic non-blinded design. The study has&#xD;
      two phases, a Retention Phase and a Discontinuation Phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Retention Phase: 3x2 for BUP; 1x2 for XR-NTX; Discontinuation Phase: 2x2 for SL-BUP; 1x2 for XR-BUP; 1x2 for XR-NTX</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention: Continuous retention in MOUD treatment at 26 weeks</measure>
    <time_frame>Retention: at week 26</time_frame>
    <description>Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap in MOUD over the 26-week period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation: Completed Discontinuation without Relapse</measure>
    <time_frame>Discontinuation: at week 24 follow up</time_frame>
    <description>Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention KS1: Weekly opioid abstinence</measure>
    <time_frame>Retention: through week 26</time_frame>
    <description>Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 3 through 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention KS2: Treatment effectiveness</measure>
    <time_frame>Retention: at week 26</time_frame>
    <description>Retention treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discontinuation KS1: Other discontinuation outcomes</measure>
    <time_frame>Discontinuation: at week 24 follow up</time_frame>
    <description>Participants who did not meet the criteria for the primary outcome (Completed Discontinuation without Relapse), will be subcategorized into 3 other outcome categories: 1) Did not Complete Discontinuation (i.e., MOUD is continued or discontinued and then restarted within the next 24 weeks) and did not Relapse; 2) Completed Discontinuation followed by Relapse; or 3) Did not Complete Discontinuation and Relapse (i.e., relapse while on MOUD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSK2: Treatment effectiveness</measure>
    <time_frame>Discontinuation: week 24 follow up</time_frame>
    <description>Discontinuation treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 24. Measured at the end of taper (EOT): up to 24 weeks for tapers with XR-NTX and up to 48 weeks for tapers with BUP; and at the week 24 follow up (primary outcome timepoint).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>R-Other 1a: Continuous opioid abstinence-weeks 23-26</measure>
    <time_frame>Retention: weeks 23-26</time_frame>
    <description>Binary indicator of continuous abstinence from opioids in weeks 23 to 26 (measured by Timeline Followback, not contradicted by toxicology test)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 1b: Continuous opioid abstinence-weeks 47-50</measure>
    <time_frame>Retention: weeks 47-50</time_frame>
    <description>Binary indicator of continuous abstinence from opioids in weeks 47 to 50 (measured by Timeline Followback, not contradicted by toxicology test)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 1c: Continuous opioid abstinence-weeks 71-74</measure>
    <time_frame>Retention: weeks 71-74</time_frame>
    <description>Binary indicator of continuous abstinence from opioids in weeks 71 to 74 (measured by Timeline Followback, not contradicted by toxicology test)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 2: Weekly opioid abstinence</measure>
    <time_frame>Retention: weeks 27-74</time_frame>
    <description>Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 27 through 74.</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 3: Weekly abstinence from other substance use</measure>
    <time_frame>Retention: weeks 0-74</time_frame>
    <description>Weekly abstinence from other substance use (measured by Timeline Followback, not contradicted by toxicology test)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 4: Craving</measure>
    <time_frame>Retention: weeks 0-98</time_frame>
    <description>Craving, measured by the Opioid Craving Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 5a: Stable abstinence at week 26</measure>
    <time_frame>Retention: week 26</time_frame>
    <description>Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 26), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 5b: Stable abstinence at week 50</measure>
    <time_frame>Retention: week 50</time_frame>
    <description>Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 50), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 5c: Stable abstinence at week 74</measure>
    <time_frame>Retention: week 74</time_frame>
    <description>Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 74), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 6: Retention in MOUD at week 50</measure>
    <time_frame>Retention: week 50</time_frame>
    <description>Point prevalence of retention in MOUD treatment (defined as no gap of 28 days or more in MOUD) at 50 weeks after date of randomization (binary, measured by Timeline Followback)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 7: Retention in MOUD at week 74</measure>
    <time_frame>Retention: week 74</time_frame>
    <description>Point prevalence of retention in MOUD treatment at 74 weeks after date of randomization, measured by TLFB</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 8: Dropout from MOUD treatment</measure>
    <time_frame>Retention: weeks 0-74</time_frame>
    <description>Dropout from MOUD treatment (time to event), i.e., a gap of 28 or more days in MOUD, event to have started at the beginning of the 28-day gap (measured by Timeline Followback)</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 9: Depression</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Depression (measured by the Patient Health Questionnaire (PHQ) 9) over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 10: Anxiety</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr) over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 11: Stress</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Stress, measured by the Perceived Stress Scale, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 12: Pain</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Pain, measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 13: Recovery capital</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 14: Negative consequences of opioid use</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 15: Sexual risk</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Sexual risk, measured by two questions regarding sexual behavior, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 16: Rate of incarceration</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Rate of incarcerations, collected on the Non-Medical and Other Services form, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>R-Other 17: Rate of homelessness</measure>
    <time_frame>Retention: weeks 0-26</time_frame>
    <description>Rate of homelessness, collected on the Study Demographics form, over the first 26 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 1: Relapse</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Relapse (time to event): defined as self-reported opioid use on more than 4 days in any consecutive 28-day period (event to begin on the first day of use), or 2 or more consecutive opioid-positive drug tests (event to begin with the first opioid-positive test) or any self-reported injection drug use (whichever comes first).</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 2: Withdrawal symptoms</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Withdrawal symptoms, measured by Subjective Opioid Withdrawal Scale (SOWS), during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 3: Craving</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Craving, measured by the Opioid Craving Scale, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 4: Depression</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Depression, measured by the Patient Health Questionnaire (PHQ) 9 item, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 5: Anxiety</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 6: Stress</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Stress, measured by the Perceived Stress Scale, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 7: Pain</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Pain, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 8a: Recovery capital (BARC-10)</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 8b: Recovery capital (RCS)</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Recovery capital, measured by the Recovery Capital Scale; six additional questions more specific to participants with OUD, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 9: Negative consequences of opioid use</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 10: Sexual risk</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Sexual risk, measured by two questions regarding sexual behavior, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 11: Rate of incarceration</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Incarcerations, collected on the Non-Medical and Other Services form, during taper and follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>D-Other 12: Rate of homelessness</measure>
    <time_frame>Discontinuation: during taper and through week 24 follow up</time_frame>
    <description>Homelessness, collected on the Study Demographics form, during taper and follow up</description>
  </other_outcome>
  <number_of_arms>16</number_of_arms>
  <enrollment type="Anticipated">2190</enrollment>
  <condition>Opioid Use Disorder (OUD)</condition>
  <arm_group>
    <arm_group_label>Retention: SL-BUP standard dose + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: SL-BUP high dose + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: XR-BUP + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: XR-NTX + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: SL-BUP standard dose + MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: SL-BUP high dose + MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: XR-BUP + MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retention: XR-NTX + MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SL-BUP</intervention_name>
    <description>Daily dosing of sublingual buprenorphine-naloxone</description>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MMD</arm_group_label>
    <arm_group_label>Retention: SL-BUP high dose + MM</arm_group_label>
    <arm_group_label>Retention: SL-BUP high dose + MMR</arm_group_label>
    <arm_group_label>Retention: SL-BUP standard dose + MM</arm_group_label>
    <arm_group_label>Retention: SL-BUP standard dose + MMR</arm_group_label>
    <other_name>sublingual buprenorphine</other_name>
    <other_name>Suboxone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XR-BUP</intervention_name>
    <description>Weekly/monthly dosing of extended-release injectable buprenorphine</description>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_label>Retention: XR-BUP + MM</arm_group_label>
    <arm_group_label>Retention: XR-BUP + MMR</arm_group_label>
    <other_name>extended-release buprenorphine</other_name>
    <other_name>CAM2038</other_name>
    <other_name>Brixadi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XR-NTX</intervention_name>
    <description>Monthly dosing of extended-release injectable naltrexone</description>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MMD</arm_group_label>
    <arm_group_label>Retention: XR-NTX + MM</arm_group_label>
    <arm_group_label>Retention: XR-NTX + MMR</arm_group_label>
    <other_name>extended-release naltrexone</other_name>
    <other_name>Vivitrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MM</intervention_name>
    <description>MM consists of standard Medical Management and the usual counseling at the treatment program.</description>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MM</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MM</arm_group_label>
    <arm_group_label>Retention: SL-BUP high dose + MM</arm_group_label>
    <arm_group_label>Retention: SL-BUP standard dose + MM</arm_group_label>
    <arm_group_label>Retention: XR-BUP + MM</arm_group_label>
    <arm_group_label>Retention: XR-NTX + MM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MMR</intervention_name>
    <description>MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.</description>
    <arm_group_label>Retention: SL-BUP high dose + MMR</arm_group_label>
    <arm_group_label>Retention: SL-BUP standard dose + MMR</arm_group_label>
    <arm_group_label>Retention: XR-BUP + MMR</arm_group_label>
    <arm_group_label>Retention: XR-NTX + MMR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MMD</intervention_name>
    <description>MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.</description>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with SL-BUP + MMD</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue SL-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-BUP with XR-BUP + MMD</arm_group_label>
    <arm_group_label>Discontinuation: Discontinue XR-NTX with XR-NTX + MMD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Retention Phase:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. Meet DSM-5 criteria for current opioid use disorder (heroin, fentanyl or other&#xD;
             synthetic opioids, and/or prescription opioids);&#xD;
&#xD;
          3. Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or&#xD;
             extended-release injection naltrexone (XR-NTX);&#xD;
&#xD;
          4. If choosing buprenorphine, willing to be randomized to SL-BUP-16mg, SL-BUP-32mg, or&#xD;
             XR-BUP;&#xD;
&#xD;
          5. Willing to be randomized to either MM (standard Medical Management plus counseling&#xD;
             treatment as usual available at the site) or MMR (MM plus usual counseling and access&#xD;
             to an app delivering CM + CBT);&#xD;
&#xD;
          6. In good-enough general health (meaning good enough health to be in outpatient&#xD;
             treatment) as determined by the study medical clinician on the basis of medical&#xD;
             history, review of systems, and physical/mental status exam, to permit treatment with&#xD;
             XR-NTX or BUP;&#xD;
&#xD;
          7. Willing and able to provide written informed consent;&#xD;
&#xD;
          8. Able to speak English sufficiently to understand the study procedures;&#xD;
&#xD;
          9. If female of childbearing potential, willing to practice an effective method of birth&#xD;
             control for the duration of participation in the study (participants who become&#xD;
             pregnant during the study will continue to be followed; treatment may be modified&#xD;
             consistent with pregnancy).&#xD;
&#xD;
        Exclusion Criteria for Retention Phase:&#xD;
&#xD;
          1. Serious medical, psychiatric, or co-occurring substance use disorder or concomitant&#xD;
             medication that, in the opinion of the study medical clinician, makes the patient not&#xD;
             appropriate for outpatient treatment with buprenorphine or XR-NTX, but instead&#xD;
             requires a higher or different level of care. Examples include:&#xD;
&#xD;
               1. Disabling or terminal medical illness (e.g., uncompensated heart failure,&#xD;
                  cirrhosis or end-stage liver disease) as assessed by medical history, review of&#xD;
                  systems, physical exam and/or laboratory assessments;&#xD;
&#xD;
               2. Severe, untreated or inadequately treated psychiatric condition (e.g., active&#xD;
                  psychosis, uncontrolled bipolar disorder) as assessed by history and/or clinical&#xD;
                  interview, requiring a different level of care (e.g., hospitalization);&#xD;
&#xD;
               3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic&#xD;
                  use, requiring a different level of care (e.g., hospitalization);&#xD;
&#xD;
          2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g.,&#xD;
             hospitalization);&#xD;
&#xD;
          3. Known allergy or sensitivity to preferred medication or its components;&#xD;
&#xD;
          4. Maintenance on methadone at the time of signing consent;&#xD;
&#xD;
          5. For those preferring XR-NTX, presence of pain of sufficient severity as to require&#xD;
             ongoing pain management with opioids;&#xD;
&#xD;
          6. For those preferring XR-NTX, body habitus that, in the judgment of the study&#xD;
             physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI&gt;40, excess fat&#xD;
             tissue over the buttocks, emaciation);&#xD;
&#xD;
          7. If female, currently pregnant or breastfeeding or planning on conception;&#xD;
&#xD;
          8. Are currently in jail, prison or other overnight facility as required by court of law&#xD;
             or have pending legal action that could prevent participation in study activities;&#xD;
&#xD;
          9. Have used the reSET-O or CHESS Connections mHealth apps in the 3 months prior to&#xD;
             consent;&#xD;
&#xD;
         10. Other major reasons that might prevent an individual from participating in the study&#xD;
             (e.g., a planned move out of the area).&#xD;
&#xD;
        Inclusion Criteria for Discontinuation Phase:&#xD;
&#xD;
          1. 18 years of age or older;&#xD;
&#xD;
          2. Have been receiving buprenorphine for OUD for at least the past year or XR-NTX&#xD;
             pharmacotherapy for OUD for at least the past 6 months prior to consent for the&#xD;
             Discontinuation Phase;&#xD;
&#xD;
          3. Express the desire to discontinue MOUD after a shared decision-making discussion with&#xD;
             the treating provider;&#xD;
&#xD;
          4. Meet stability criteria, i.e., have abstained from opioids (other than buprenorphine),&#xD;
             cocaine, methamphetamine, and non-prescribed benzodiazepines for the past ≥12 weeks,&#xD;
             and do not meet DSM-5 criteria for current (≥12 weeks) alcohol use disorder&#xD;
             (participants with cannabis use will be eligible);&#xD;
&#xD;
          5. If currently taking buprenorphine, are willing to take either SL-BUP or XR-BUP if&#xD;
             randomized to that condition;&#xD;
&#xD;
          6. Willing to be randomized to either MM or to MMD;&#xD;
&#xD;
          7. Able to provide written informed consent after discussion with their provider&#xD;
             regarding the risks of discontinuation;&#xD;
&#xD;
          8. Able to speak English sufficiently to understand the study procedures;&#xD;
&#xD;
          9. If female of childbearing potential, willing to practice an effective method of birth&#xD;
             control while in the study and taking study medication (participants who become&#xD;
             pregnant during the study will continue to be followed; treatment may be modified&#xD;
             consistent with pregnancy).&#xD;
&#xD;
        Exclusion Criteria for Discontinuation Phase:&#xD;
&#xD;
          1. Serious medical or psychiatric disorder or concomitant medication that, in the opinion&#xD;
             of the study medical clinician, would make study participation hazardous to the&#xD;
             participant or compromise study findings or would prevent the participant from&#xD;
             completing the study. Examples include:&#xD;
&#xD;
               1. Disabling or terminal medical illness (e.g., uncompensated heart failure,&#xD;
                  cirrhosis or end-stage liver disease) as assessed by medical history, review of&#xD;
                  systems, physical exam and/or laboratory assessments;&#xD;
&#xD;
               2. Severe, untreated, or inadequately treated psychiatric condition (e.g., active&#xD;
                  psychosis, uncontrolled bipolar disorder) as assessed by history and/or clinical&#xD;
                  interview, requiring a different level of care (e.g., hospitalization);&#xD;
&#xD;
          2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g.,&#xD;
             hospitalization);&#xD;
&#xD;
          3. For participants entering the study taking buprenorphine, presence of pain requiring&#xD;
             or likely requiring ongoing pain management with buprenorphine or other opioids;&#xD;
&#xD;
          4. If female, currently pregnant or breastfeeding or planning on conception;&#xD;
&#xD;
          5. Use of opioids (other than buprenorphine), cocaine, methamphetamine, or non-prescribed&#xD;
             benzodiazepines in the past 12 weeks;&#xD;
&#xD;
          6. Meets current DSM-5 criteria for any current alcohol use disorder;&#xD;
&#xD;
          7. Are currently in jail, prison or other overnight facility as required by court of law&#xD;
             or have pending legal action that could prevent participation in study activities;&#xD;
&#xD;
          8. Have used the Connections mHealth app in the 3 months prior to consent (other than&#xD;
             Connections in the Retention Phase);&#xD;
&#xD;
          9. Other major reasons that might prevent an individual from participating in the study&#xD;
             (e.g., a planned move out of the area.&#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>Edward V Nunes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute/Columbia University Irving Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Rotrosen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Grossman School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roger Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard Medical School/McLean Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Project Manager</last_name>
    <phone>646-754-4786</phone>
    <email>RDD@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences (UAMS) / Center for Addiction Services and Treatment (CAST)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alyssah Locklear, MS</last_name>
      <phone>501-526-8423</phone>
      <email>alocklear@uams.edu</email>
    </contact>
    <investigator>
      <last_name>Alison Oliveto, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tarzana Treatment Centers, Inc.</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tolib M Rakhmanov</last_name>
      <phone>818-996-1051</phone>
      <phone_ext>3143</phone_ext>
      <email>tolibrakhmanov@tarzanatc.org</email>
    </contact>
    <contact_backup>
      <last_name>Edgardo Mota Lozano</last_name>
      <phone>818-996-1051</phone>
      <phone_ext>1336</phone_ext>
      <email>ctnresearch@tarzanatc.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kenneth M Bachrach, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liberation Programs, Inc.</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Beth Pamias</last_name>
      <phone>203-520-6392</phone>
      <email>marybeth.dezenzo@liberationprograms.org</email>
    </contact>
    <contact_backup>
      <last_name>Joanne Montgomery</last_name>
      <phone>203-913-6439</phone>
      <email>joanne.montgomery@liberationprograms.org</email>
    </contact_backup>
    <investigator>
      <last_name>John Hamilton, LMFT, LADC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Operation PAR</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33760</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Czaicki, MD, MPH</last_name>
      <phone>727-507-4447</phone>
      <email>nczaicki@operpar.org</email>
    </contact>
    <investigator>
      <last_name>Michael Sheehan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gateway Community Services</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Seim</last_name>
      <phone>904-387-4661</phone>
      <phone_ext>1090</phone_ext>
      <email>jseim@gwjax.com</email>
    </contact>
    <contact_backup>
      <last_name>Sarah Kim, BA</last_name>
      <phone>904-387-4661</phone>
      <phone_ext>1073</phone_ext>
      <email>skim@gwjax.com</email>
    </contact_backup>
    <investigator>
      <last_name>Candace Hodgkins, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raymond Pomm, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aspire Health Partners</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristen Lewandowski, PhD</last_name>
      <phone>407-875-3700</phone>
      <phone_ext>2877</phone_ext>
      <email>Kristen.Lewandowskiponzio@aspirehp.org</email>
    </contact>
    <contact_backup>
      <last_name>Christopher Lazo</last_name>
      <phone>407-967-5681</phone>
      <email>Christopher.Lazo@aspirehp.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kristen Lewandowski, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mountain Manor / Maryland Treatment Centers</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Carrano, PhD</last_name>
      <phone>410-233-1400</phone>
      <email>jcarrano@marylandtreatment.org</email>
    </contact>
    <contact_backup>
      <last_name>Kevin Wenzel, PhD</last_name>
      <phone>410-233-1400</phone>
      <email>kwenzel@marylandtreatment.org</email>
    </contact_backup>
    <investigator>
      <last_name>Marc Fishman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Syed Asad Hassan Bokhari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ann Bennett Bruner, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jennifer Carrano, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kevin Wenzel, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanley Street Treatment and Resources, Inc.</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Stang</last_name>
      <phone>508-324-3522</phone>
      <email>rdd@sstar.org</email>
    </contact>
    <contact_backup>
      <last_name>Genie L Bailey, MD</last_name>
      <phone>508-324-3565</phone>
      <email>genie@SSTAR.org</email>
    </contact_backup>
    <investigator>
      <last_name>Genie L Bailey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Square Medical Group, LLC</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Team</last_name>
      <phone>617-916-5069</phone>
      <phone_ext>307</phone_ext>
      <email>RDD@partners.org</email>
    </contact>
    <contact_backup>
      <last_name>Research Team</last_name>
      <phone>617-610-2169</phone>
    </contact_backup>
    <investigator>
      <last_name>Natalie Lender, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jungjin Kim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gibson Center for Behavioral Change</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Naeger, MSW</last_name>
      <phone>573-332-0416</phone>
      <phone_ext>158</phone_ext>
      <email>naegera@gibsonrecovery.org</email>
    </contact>
    <investigator>
      <last_name>Ashley Naeger, MSW</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Gary</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock - ATP</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Coordinator</last_name>
      <phone>603-653-1824</phone>
      <email>RDDstudy@hitchcock.org</email>
    </contact>
    <contact_backup>
      <last_name>Chantal Lambert-Harris, MA</last_name>
      <phone>603-646-7007</phone>
      <email>chantal.a.lambert-harris@dartmouth.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Luke Archibald, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Addiction and Substance Abuse Program</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cade Arnink</last_name>
      <phone>505-225-6931</phone>
      <email>clarnink@salud.unm.edu</email>
    </contact>
    <investigator>
      <last_name>Snehal Bhatt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bellevue Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Coordinator</last_name>
      <phone>646-501-4138</phone>
      <email>Bellevue.RDDStudy@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Mathew Kladney, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Adapt Integrated Health Care</name>
      <address>
        <city>Roseburg</city>
        <state>Oregon</state>
        <zip>97470</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessie Mazelin</last_name>
      <phone>541-900-7434</phone>
      <email>jessiem@adaptoregon.org</email>
    </contact>
    <contact_backup>
      <last_name>Research Coordinator</last_name>
      <phone>541-492-4550</phone>
      <phone_ext>4546</phone_ext>
    </contact_backup>
    <investigator>
      <last_name>Cora Hart, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Adapt Integrated Health Care</name>
      <address>
        <city>Winston</city>
        <state>Oregon</state>
        <zip>97496</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessie Mazelin</last_name>
      <phone>541-900-7434</phone>
      <email>jessiem@adaptoregon.org</email>
    </contact>
    <contact_backup>
      <last_name>Research Coordinator</last_name>
      <phone>541-492-4500</phone>
      <phone_ext>4546</phone_ext>
    </contact_backup>
    <investigator>
      <last_name>Cora Hart, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Center for Psychiatric and Chemical Dependency Services (CPCDS)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronna Currie, BS</last_name>
      <phone>412-956-2503</phone>
      <email>currier@pitt.edu</email>
    </contact>
    <contact_backup>
      <last_name>Donna Olejniczak, MPS, MBA</last_name>
      <phone>412-624-7263</phone>
      <email>dmo36@pitt.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Antoine Douaihy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Internal Medicine Recovery Engagement Program (IM-REP)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronna Currie, BS</last_name>
      <phone>412-956-2503</phone>
      <email>currier@pitt.edu</email>
    </contact>
    <contact_backup>
      <last_name>Donna Olejniczak, MPS, MBA</last_name>
      <phone>412-624-7263</phone>
      <email>dmo36@pitt.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Antoine Douaihy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shoreline Behavioral Health Services</name>
      <address>
        <city>Conway</city>
        <state>South Carolina</state>
        <zip>29526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristian Edwards</last_name>
      <phone>843-855-2603</phone>
      <email>kedwards@shorelinebhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Rachel Nance</last_name>
      <phone>843-438-3162</phone>
      <email>rnance@shorelinebhs.org</email>
    </contact_backup>
    <investigator>
      <last_name>Kelly S Barth, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huntsman Mental Health Institute / University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Coordinator</last_name>
      <email>RDDstudy@utah.edu</email>
    </contact>
    <contact_backup>
      <last_name>Brady Groneman, BA</last_name>
      <phone>385-256-3882</phone>
      <email>brady.groneman@hsc.utah.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Elizabeth Howell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeremy Thueson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chestnut Ridge Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lacey Kelley, BSN</last_name>
      <phone>304-276-3828</phone>
      <email>lkelley5@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Laura Lander, MSW, AADC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 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>
    <mesh_term>Substance-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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).&#xD;
Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/.&#xD;
The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_url>https://datashare.nida.nih.gov</ipd_url>
  </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/NCT04464980
org study id: 19-01363
secondary id: CTN-0100
secondary id: UG1DA013035
secondary id: UG1DA015831
secondary id: 20-PRS-057
secondary id: 146193
nct id: NCT04464980
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a two phase study investigating combinations of pharmacological and behavioral
      interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase
      will assess strategies for improving retention on buprenorphine (BUP) and extended-release
      injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are
      most likely to lead to long-term success (absence of relapse), and what characteristics of
      participants distinguish those who can safely discontinue Medications for Opioid Use Disorder
      (MOUD) from those who remain at risk of relapse and should not discontinue.
The main objectives of this study are:

        1. To test strategies to improve retention in treatment on medications for opioid use
           disorder (MOUD), among patients initiating treatment for OUD.

        2. To test strategies to improve outcomes among patients who have achieved stable remission
           on MOUD and want to discontinue MOUD.

        3. To develop models to predict who is able to discontinue MOUD without relapse, based on
           patient characteristics, including duration of MOUD prior to discontinuation.

      The study will have a multicenter, randomized, pragmatic non-blinded design. The study has
      two phases, a Retention Phase and a Discontinuation Phase.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Retention Phase: 3x2 for BUP; 1x2 for XR-NTX; Discontinuation Phase: 2x2 for SL-BUP; 1x2 for XR-BUP; 1x2 for XR-NTX
primary purpose: Treatment
masking: None (Open Label)
measure: Retention: Continuous retention in MOUD treatment at 26 weeks
time frame: Retention: at week 26
description: Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap in MOUD over the 26-week period.
measure: Discontinuation: Completed Discontinuation without Relapse
time frame: Discontinuation: at week 24 follow up
description: Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued.
measure: Retention KS1: Weekly opioid abstinence
time frame: Retention: through week 26
description: Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 3 through 26.
measure: Retention KS2: Treatment effectiveness
time frame: Retention: at week 26
description: Retention treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 26.
measure: Discontinuation KS1: Other discontinuation outcomes
time frame: Discontinuation: at week 24 follow up
description: Participants who did not meet the criteria for the primary outcome (Completed Discontinuation without Relapse), will be subcategorized into 3 other outcome categories: 1) Did not Complete Discontinuation (i.e., MOUD is continued or discontinued and then restarted within the next 24 weeks) and did not Relapse; 2) Completed Discontinuation followed by Relapse; or 3) Did not Complete Discontinuation and Relapse (i.e., relapse while on MOUD).
measure: DSK2: Treatment effectiveness
time frame: Discontinuation: week 24 follow up
description: Discontinuation treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 24. Measured at the end of taper (EOT): up to 24 weeks for tapers with XR-NTX and up to 48 weeks for tapers with BUP; and at the week 24 follow up (primary outcome timepoint).
measure: R-Other 1a: Continuous opioid abstinence-weeks 23-26
time frame: Retention: weeks 23-26
description: Binary indicator of continuous abstinence from opioids in weeks 23 to 26 (measured by Timeline Followback, not contradicted by toxicology test)
measure: R-Other 1b: Continuous opioid abstinence-weeks 47-50
time frame: Retention: weeks 47-50
description: Binary indicator of continuous abstinence from opioids in weeks 47 to 50 (measured by Timeline Followback, not contradicted by toxicology test)
measure: R-Other 1c: Continuous opioid abstinence-weeks 71-74
time frame: Retention: weeks 71-74
description: Binary indicator of continuous abstinence from opioids in weeks 71 to 74 (measured by Timeline Followback, not contradicted by toxicology test)
measure: R-Other 2: Weekly opioid abstinence
time frame: Retention: weeks 27-74
description: Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 27 through 74.
measure: R-Other 3: Weekly abstinence from other substance use
time frame: Retention: weeks 0-74
description: Weekly abstinence from other substance use (measured by Timeline Followback, not contradicted by toxicology test)
measure: R-Other 4: Craving
time frame: Retention: weeks 0-98
description: Craving, measured by the Opioid Craving Scale
measure: R-Other 5a: Stable abstinence at week 26
time frame: Retention: week 26
description: Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 26), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)
measure: R-Other 5b: Stable abstinence at week 50
time frame: Retention: week 50
description: Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 50), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)
measure: R-Other 5c: Stable abstinence at week 74
time frame: Retention: week 74
description: Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 74), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)
measure: R-Other 6: Retention in MOUD at week 50
time frame: Retention: week 50
description: Point prevalence of retention in MOUD treatment (defined as no gap of 28 days or more in MOUD) at 50 weeks after date of randomization (binary, measured by Timeline Followback)
measure: R-Other 7: Retention in MOUD at week 74
time frame: Retention: week 74
description: Point prevalence of retention in MOUD treatment at 74 weeks after date of randomization, measured by TLFB
measure: R-Other 8: Dropout from MOUD treatment
time frame: Retention: weeks 0-74
description: Dropout from MOUD treatment (time to event), i.e., a gap of 28 or more days in MOUD, event to have started at the beginning of the 28-day gap (measured by Timeline Followback)
measure: R-Other 9: Depression
time frame: Retention: weeks 0-26
description: Depression (measured by the Patient Health Questionnaire (PHQ) 9) over the first 26 weeks
measure: R-Other 10: Anxiety
time frame: Retention: weeks 0-26
description: Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr) over the first 26 weeks
measure: R-Other 11: Stress
time frame: Retention: weeks 0-26
description: Stress, measured by the Perceived Stress Scale, over the first 26 weeks
measure: R-Other 12: Pain
time frame: Retention: weeks 0-26
description: Pain, measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), over the first 26 weeks
measure: R-Other 13: Recovery capital
time frame: Retention: weeks 0-26
description: Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, over the first 26 weeks
measure: R-Other 14: Negative consequences of opioid use
time frame: Retention: weeks 0-26
description: Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, over the first 26 weeks
measure: R-Other 15: Sexual risk
time frame: Retention: weeks 0-26
description: Sexual risk, measured by two questions regarding sexual behavior, over the first 26 weeks
measure: R-Other 16: Rate of incarceration
time frame: Retention: weeks 0-26
description: Rate of incarcerations, collected on the Non-Medical and Other Services form, over the first 26 weeks
measure: R-Other 17: Rate of homelessness
time frame: Retention: weeks 0-26
description: Rate of homelessness, collected on the Study Demographics form, over the first 26 weeks
measure: D-Other 1: Relapse
time frame: Discontinuation: during taper and through week 24 follow up
description: Relapse (time to event): defined as self-reported opioid use on more than 4 days in any consecutive 28-day period (event to begin on the first day of use), or 2 or more consecutive opioid-positive drug tests (event to begin with the first opioid-positive test) or any self-reported injection drug use (whichever comes first).
measure: D-Other 2: Withdrawal symptoms
time frame: Discontinuation: during taper and through week 24 follow up
description: Withdrawal symptoms, measured by Subjective Opioid Withdrawal Scale (SOWS), during taper and follow up
measure: D-Other 3: Craving
time frame: Discontinuation: during taper and through week 24 follow up
description: Craving, measured by the Opioid Craving Scale, during taper and follow up
measure: D-Other 4: Depression
time frame: Discontinuation: during taper and through week 24 follow up
description: Depression, measured by the Patient Health Questionnaire (PHQ) 9 item, during taper and follow up
measure: D-Other 5: Anxiety
time frame: Discontinuation: during taper and through week 24 follow up
description: Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up
measure: D-Other 6: Stress
time frame: Discontinuation: during taper and through week 24 follow up
description: Stress, measured by the Perceived Stress Scale, during taper and follow up
measure: D-Other 7: Pain
time frame: Discontinuation: during taper and through week 24 follow up
description: Pain, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up
measure: D-Other 8a: Recovery capital (BARC-10)
time frame: Discontinuation: during taper and through week 24 follow up
description: Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, during taper and follow up
measure: D-Other 8b: Recovery capital (RCS)
time frame: Discontinuation: during taper and through week 24 follow up
description: Recovery capital, measured by the Recovery Capital Scale; six additional questions more specific to participants with OUD, during taper and follow up
measure: D-Other 9: Negative consequences of opioid use
time frame: Discontinuation: during taper and through week 24 follow up
description: Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, during taper and follow up
measure: D-Other 10: Sexual risk
time frame: Discontinuation: during taper and through week 24 follow up
description: Sexual risk, measured by two questions regarding sexual behavior, during taper and follow up
measure: D-Other 11: Rate of incarceration
time frame: Discontinuation: during taper and through week 24 follow up
description: Incarcerations, collected on the Non-Medical and Other Services form, during taper and follow up
measure: D-Other 12: Rate of homelessness
time frame: Discontinuation: during taper and through week 24 follow up
description: Homelessness, collected on the Study Demographics form, during taper and follow up
arm group label: Retention: SL-BUP standard dose + MM
arm group type: Experimental
description: Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Retention: SL-BUP high dose + MM
arm group type: Experimental
description: High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Retention: XR-BUP + MM
arm group type: Experimental
description: Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Retention: XR-NTX + MM
arm group type: Experimental
description: Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Retention: SL-BUP standard dose + MMR
arm group type: Experimental
description: Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Retention: SL-BUP high dose + MMR
arm group type: Experimental
description: High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Retention: XR-BUP + MMR
arm group type: Experimental
description: Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Retention: XR-NTX + MMR
arm group type: Experimental
description: Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MM
arm group type: Experimental
description: Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MM
arm group type: Experimental
description: Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MM
arm group type: Experimental
description: Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MM
arm group type: Experimental
description: Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
arm group type: Experimental
description: Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
arm group type: Experimental
description: Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
arm group type: Experimental
description: Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
arm group type: Experimental
description: Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
intervention type: Drug
intervention name: SL-BUP
description: Daily dosing of sublingual buprenorphine-naloxone
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MM
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
arm group label: Retention: SL-BUP high dose + MM
arm group label: Retention: SL-BUP high dose + MMR
arm group label: Retention: SL-BUP standard dose + MM
arm group label: Retention: SL-BUP standard dose + MMR
other name: sublingual buprenorphine
other name: Suboxone
intervention type: Drug
intervention name: XR-BUP
description: Weekly/monthly dosing of extended-release injectable buprenorphine
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MM
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MM
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
arm group label: Retention: XR-BUP + MM
arm group label: Retention: XR-BUP + MMR
other name: extended-release buprenorphine
other name: CAM2038
other name: Brixadi
intervention type: Drug
intervention name: XR-NTX
description: Monthly dosing of extended-release injectable naltrexone
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MM
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
arm group label: Retention: XR-NTX + MM
arm group label: Retention: XR-NTX + MMR
other name: extended-release naltrexone
other name: Vivitrol
intervention type: Behavioral
intervention name: MM
description: MM consists of standard Medical Management and the usual counseling at the treatment program.
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MM
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MM
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MM
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MM
arm group label: Retention: SL-BUP high dose + MM
arm group label: Retention: SL-BUP standard dose + MM
arm group label: Retention: XR-BUP + MM
arm group label: Retention: XR-NTX + MM
intervention type: Behavioral
intervention name: MMR
description: MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Retention: SL-BUP high dose + MMR
arm group label: Retention: SL-BUP standard dose + MMR
arm group label: Retention: XR-BUP + MMR
arm group label: Retention: XR-NTX + MMR
intervention type: Behavioral
intervention name: MMD
description: MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
arm group label: Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
arm group label: Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
arm group label: Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
arm group label: Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edward V Nunes, MD
role: Principal Investigator
affiliation: New York State Psychiatric Institute/Columbia University Irving Medical Center
last name: John Rotrosen, MD
role: Principal Investigator
affiliation: NYU Grossman School of Medicine
last name: Roger Weiss, MD
role: Principal Investigator
affiliation: Harvard Medical School/McLean Hospital
last name: Project Manager
phone: 646-754-4786
email: RDD@nyulangone.org
facility: 
status: Recruiting
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investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Substance-Related Disorders
mesh term: Naltrexone
mesh term: Buprenorphine
sharing ipd: Yes
ipd description: This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).
Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/.
The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd url: https://datashare.nida.nih.gov