xml: <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/NCT05980260</url>
    </required_header>
    <id_info>
      <org_study_id>HELP for NOWS 02</org_study_id>
      <secondary_id>1U24HD107621</secondary_id>
      <secondary_id>1UG1HD107628</secondary_id>
      <secondary_id>1UG1HD107580</secondary_id>
      <secondary_id>1UG1HD107649</secondary_id>
      <secondary_id>1UG1HD107650</secondary_id>
      <secondary_id>1UG1HD107653</secondary_id>
      <secondary_id>1UG1HD107627</secondary_id>
      <secondary_id>1UG1HD107631</secondary_id>
      <secondary_id>1UG1HD107616</secondary_id>
      <nct_id>NCT05980260</nct_id>
    </id_info>
    <brief_title>Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach</brief_title>
    <acronym>OPTimize NOW</acronym>
    <official_title>Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HELP for NOWS Consortium</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>HELP for NOWS Consortium</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial will help us learn more about how to best care for babies with Neonatal&#xD;
        Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard&#xD;
        time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need&#xD;
        medicine. Doctors have two ways of providing medicine that are widely used today:&#xD;
  &#xD;
          1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms&#xD;
             get better, the amount of medicine the baby gets decreases until the baby no longer&#xD;
             needs medicine. This is called a medicine taper.&#xD;
  &#xD;
          2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS,&#xD;
             instead of at regular times. If the baby is showing no signs of NOWS, no medicine will&#xD;
             be given.&#xD;
  &#xD;
        We are doing the OPTimize NOW study to figure out the best way to give medicine to babies&#xD;
        with NOWS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This two-period cluster crossover clinical trial will compare the length of time from birth&#xD;
        until medically ready for discharge between infants with neonatal opioid withdrawal syndrome&#xD;
        (NOWS) who are ≥ 36 weeks' gestation, at risk for pharmacologic treatment, and treated for&#xD;
        NOWS with either a symptom-based dosing approach or a scheduled opioid taper approach.&#xD;
  &#xD;
        Each study site (i.e., cluster) will be randomized in a 1:1 allocation ratio to one of two&#xD;
        sequences:&#xD;
  &#xD;
          -  Scheduled opioid taper approach for 5 months (Period 1) followed by a two-week washout&#xD;
             period following by symptom-based dosing approach for 5 months (Period 2)&#xD;
  &#xD;
          -  Symptom-based dosing approach for 5 months (Period 1) followed by a two-week washout&#xD;
             period followed by scheduled opioid taper approach for 5 months (Period 2)&#xD;
  &#xD;
        The randomization scheme will be stratified by the assessment and management approach used at&#xD;
        each study site (i.e., Finnegan or Eat, Seep and Console).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 15, 2024</start_date>
    <completion_date type="Anticipated">May 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 15, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>A two-period cluster crossover design will be used in this study. Study sites will be randomized in a 1:1 allocation ratio to one of two sequences:&#xD;
  A scheduled opioid taper approach for 5 months followed by a two-week washout period followed by a symptom-based dosing approach for 5 months.&#xD;
  A symptom-based dosing approach for 5 months followed by a two-week washout period followed by a scheduled opioid taper approach for 5 months.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time from birth until medically ready for discharge</measure>
      <time_frame>From date of birth until hospital discharge or 1 year, whichever comes first.</time_frame>
      <description>Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:&#xD;
  ≥ 96 hours of age&#xD;
  ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Receipt of pharmacologic treatment</measure>
      <time_frame>From date of birth until hospital discharge or 1 year, whichever comes first.</time_frame>
      <description>If the infant received opioid replacement therapy, prior to hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>From date of birth until hospital discharge or 1 year, whichever comes first.</time_frame>
      <description>Number of days infant remained in the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total number opioid doses</measure>
      <time_frame>From date of birth until hospital discharge or 1 year, whichever comes first.</time_frame>
      <description>The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Receipt of secondary medications</measure>
      <time_frame>From date of birth until hospital discharge or 1 year, whichever comes first.</time_frame>
      <description>The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Neonatal Opiate Withdrawal Syndrome</condition>
    <arm_group>
      <arm_group_label>Sequence 1</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This sequence will assign eligible participants to scheduled opioid taper approach for 5 months followed by a 2-week washout period followed by symptom-based dosing approach for 5 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sequence 2</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This sequence will assign eligible participants to symptom-based dosing approach for 5 months followed by a 2-week washout period followed by scheduled opioid taper approach for 5 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Symptom-based Dosing Approach</intervention_name>
      <description>During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period (midnight to midnight) to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.</description>
      <arm_group_label>Sequence 1</arm_group_label>
      <arm_group_label>Sequence 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Scheduled Opioid Taper Approach</intervention_name>
      <description>• During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.</description>
      <arm_group_label>Sequence 1</arm_group_label>
      <arm_group_label>Sequence 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The infant is greater than or equal to 36 weeks gestation.&#xD;
  &#xD;
            2. The infant had antenatal opioid exposure identified by at least one of the following:&#xD;
  &#xD;
                 -  History of maternal opioid use during pregnancy;&#xD;
  &#xD;
                 -  Positive maternal toxicology screen for opioids during the second or third&#xD;
                    trimester of pregnancy; and/or&#xD;
  &#xD;
                 -  Positive infant toxicology screen for opioids during the initial hospital stay.&#xD;
  &#xD;
            3. The infant is being assessed and managed for NOWS at an eligible study site.&#xD;
  &#xD;
            4. The infant is at risk for pharmacologic treatment for NOWS defined by either of the&#xD;
               following&#xD;
  &#xD;
                 -  At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof&#xD;
  &#xD;
                 -  At least 1 &quot;yes&quot; if assessed and managed with the ESC care approach&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The infant has major birth defect(s).&#xD;
  &#xD;
            2. The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy),&#xD;
               a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior&#xD;
               to the initiation of pharmacologic treatment.&#xD;
  &#xD;
            3. The infant is receiving respiratory support (any positive pressure or oxygen therapy)&#xD;
               at 48 hours of age.&#xD;
  &#xD;
            4. The infant has undergone major surgical intervention prior to or at 48 hours of age.&#xD;
  &#xD;
            5. The infant has postnatal opioid exposure prior to the initiation of treatment for&#xD;
               NOWS.&#xD;
  &#xD;
            6. The infant was outborn and pharmacologic treatment was initiated at the transferring&#xD;
               hospital.&#xD;
  &#xD;
            7. The infant is assessed for eligibility during the study site's two-week washout&#xD;
               period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Hour</minimum_age>
      <maximum_age>48 Hours</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lori Devlin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Louisville</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HELP for NOWS Consortium</last_name>
      <phone>202-974-7837</phone>
      <email>HELPforNOWS@rti.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Namasivayam Ambalavanan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Namasivayam Ambalavanan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Arkansas for Medical Sciences</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Richard Hall, MD</last_name>
      </contact>
      <investigator>
        <last_name>Richard Hall, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sidney &amp; Lois Eskenazi Hospital</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Gregory Sokol, MD</last_name>
      </contact>
      <investigator>
        <last_name>Gregory Sokol, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Louisville Hospital</name>
        <address>
          <city>Jeffersonville</city>
          <state>Indiana</state>
          <zip>47130</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Scott Duncan, MD</last_name>
      </contact>
      <investigator>
        <last_name>Scott Duncan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>St. Elizabeth Healthcare</name>
        <address>
          <city>Edgewood</city>
          <state>Kentucky</state>
          <zip>41017</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephanie Merhar, MD, MS</last_name>
      </contact>
      <investigator>
        <last_name>Stephanie Merhar, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Norton Children's Hospital</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sucheta Telang, MD</last_name>
      </contact>
      <investigator>
        <last_name>Sucheta Telang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of New Mexico Health Sciences Center</name>
        <address>
          <city>Albuquerque</city>
          <state>New Mexico</state>
          <zip>87131</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lawrence Leeman, MD, MPH</last_name>
      </contact>
      <investigator>
        <last_name>Lawrence Leeman, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Good Samaritan Hospital</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephanie Merhar, MD, MS</last_name>
        <phone>513-803-5180</phone>
      </contact>
      <investigator>
        <last_name>Stephanie Merhar, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Cincinnati Children's Hospital Medical Center</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45229</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephanie Merhar, MD, MS</last_name>
        <phone>513-803-5180</phone>
      </contact>
      <investigator>
        <last_name>Stephanie Merhar, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://helpfornows.rti.org</url>
      <description>Related Info</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NOWS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Substance Withdrawal Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Analgesics, Opioid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data collected for this study will be analyzed and stored at the DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) and NICHD requirements for data-sharing will apply. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. In accordance with these policies (available at HEAL Public Access and Data Sharing | NIH HEAL Initiative), we will share de-identified data collected for the study. After the study is completed, the de-identified, archived data will be transmitted to a NIH HEAL supported repository, for use by other researchers including those outside of the study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Within 1 year of study completion.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980260
  org study id: HELP for NOWS 02
  secondary id: 1U24HD107621
  secondary id: 1UG1HD107628
  secondary id: 1UG1HD107580
  secondary id: 1UG1HD107649
  secondary id: 1UG1HD107650
  secondary id: 1UG1HD107653
  secondary id: 1UG1HD107627
  secondary id: 1UG1HD107631
  secondary id: 1UG1HD107616
  nct id: NCT05980260
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial will help us learn more about how to best care for babies with Neonatal
        Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard
        time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need
        medicine. Doctors have two ways of providing medicine that are widely used today:
  
          1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms
             get better, the amount of medicine the baby gets decreases until the baby no longer
             needs medicine. This is called a medicine taper.
  
          2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS,
             instead of at regular times. If the baby is showing no signs of NOWS, no medicine will
             be given.
  
        We are doing the OPTimize NOW study to figure out the best way to give medicine to babies
        with NOWS.
  This two-period cluster crossover clinical trial will compare the length of time from birth
        until medically ready for discharge between infants with neonatal opioid withdrawal syndrome
        (NOWS) who are ≥ 36 weeks' gestation, at risk for pharmacologic treatment, and treated for
        NOWS with either a symptom-based dosing approach or a scheduled opioid taper approach.
  
        Each study site (i.e., cluster) will be randomized in a 1:1 allocation ratio to one of two
        sequences:
  
          -  Scheduled opioid taper approach for 5 months (Period 1) followed by a two-week washout
             period following by symptom-based dosing approach for 5 months (Period 2)
  
          -  Symptom-based dosing approach for 5 months (Period 1) followed by a two-week washout
             period followed by scheduled opioid taper approach for 5 months (Period 2)
  
        The randomization scheme will be stratified by the assessment and management approach used at
        each study site (i.e., Finnegan or Eat, Seep and Console).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: A two-period cluster crossover design will be used in this study. Study sites will be randomized in a 1:1 allocation ratio to one of two sequences:
  A scheduled opioid taper approach for 5 months followed by a two-week washout period followed by a symptom-based dosing approach for 5 months.
  A symptom-based dosing approach for 5 months followed by a two-week washout period followed by a scheduled opioid taper approach for 5 months.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time from birth until medically ready for discharge
  time frame: From date of birth until hospital discharge or 1 year, whichever comes first.
  description: Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria:
  ≥ 96 hours of age
  ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)
  measure: Receipt of pharmacologic treatment
  time frame: From date of birth until hospital discharge or 1 year, whichever comes first.
  description: If the infant received opioid replacement therapy, prior to hospital discharge
  measure: Length of hospital stay
  time frame: From date of birth until hospital discharge or 1 year, whichever comes first.
  description: Number of days infant remained in the hospital
  measure: Total number opioid doses
  time frame: From date of birth until hospital discharge or 1 year, whichever comes first.
  description: The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.
  measure: Receipt of secondary medications
  time frame: From date of birth until hospital discharge or 1 year, whichever comes first.
  description: The total number of opioid doses administered among all infants pharmacologically treated during intital hospitilizatoin.
  arm group label: Sequence 1
  arm group type: Other
  description: This sequence will assign eligible participants to scheduled opioid taper approach for 5 months followed by a 2-week washout period followed by symptom-based dosing approach for 5 months.
  arm group label: Sequence 2
  arm group type: Other
  description: This sequence will assign eligible participants to symptom-based dosing approach for 5 months followed by a 2-week washout period followed by scheduled opioid taper approach for 5 months.
  intervention type: Other
  intervention name: Symptom-based Dosing Approach
  description: During this approach to care, all enrolled infants with NOWS at the study site will be treated with the symptom-based dosing approach if they meet the withdrawal threshold for pharmacologic treatment. Participants may receive up to 3 doses of the study site's preferred opioid during a 24-hour period (midnight to midnight) to treat signs of withdrawal once the threshold for pharmacologic intervention is met. If a 4th dose is required within a 24-hour period, the study site will transition to the scheduled opioid taper algorithm used at the study site to complete the infant's pharmacologic treatment.
  arm group label: Sequence 1
  arm group label: Sequence 2
  intervention type: Other
  intervention name: Scheduled Opioid Taper Approach
  description: • During this approach to care, all enrolled infants with NOWS at the study site will be treated with the study site's usual scheduled opioid taper approach, as detailed in each site's treatment algorithm, if they meet the withdrawal threshold for pharmacologic treatment.
  arm group label: Sequence 1
  arm group label: Sequence 2
  criteria: 
  gender: All
  minimum age: 1 Hour
  maximum age: 48 Hours
  healthy volunteers: No
  last name: Lori Devlin, MD
  role: Principal Investigator
  affiliation: University of Louisville
  last name: HELP for NOWS Consortium
  phone: 202-974-7837
  email: HELPforNOWS@rti.org
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  url: http://helpfornows.rti.org
  description: Related Info
  responsible party type: Sponsor
  mesh term: Syndrome
  mesh term: Substance Withdrawal Syndrome
  mesh term: Analgesics, Opioid
  sharing ipd: Yes
  ipd description: Data collected for this study will be analyzed and stored at the DCC, RTI International. NIH Helping to End Addiction Long-term Initiative (HEAL) and NICHD requirements for data-sharing will apply. NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. In accordance with these policies (available at HEAL Public Access and Data Sharing | NIH HEAL Initiative), we will share de-identified data collected for the study. After the study is completed, the de-identified, archived data will be transmitted to a NIH HEAL supported repository, for use by other researchers including those outside of the study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Within 1 year of study completion.