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/NCT06008990</url>
    </required_header>
    <id_info>
      <org_study_id>RADY-IIR-19466</org_study_id>
      <secondary_id>1R03DA056797-01A1</secondary_id>
      <nct_id>NCT06008990</nct_id>
    </id_info>
    <brief_title>Maternal Brain Imaging in Opioid Use Disorder</brief_title>
    <official_title>Maternal Brain Imaging in Opioid Use Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indiana University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Indiana University</source>
    <oversight_info>
      <has_dmc>No</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 research study aims to learn more about opioid use disorder (OUD) during pregnancy and&#xD;
        how outcomes for pregnant women and their newborns can be improved. During pregnancy, people&#xD;
        with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested&#xD;
        to know how the medication is broken down by the body during pregnancy and how effective it&#xD;
        is. The investigators also want to learn if this medication and OUD have any effect on the&#xD;
        different parts of the brain when compared to mothers without OUD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI.</measure>
      <time_frame>During MRI visit between 24-32 weeks gestational age</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD</measure>
      <time_frame>During MRI visit between 24-32 weeks gestational age</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.</measure>
      <time_frame>During MRI visit between 24-32 weeks gestational age</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.</measure>
      <time_frame>During MRI visit between 24-32 weeks gestational age</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD</measure>
      <time_frame>During MRI visit between 24-32 weeks gestational age</time_frame>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Opioid Use Disorder</condition>
    <condition>Substance-Related Disorders</condition>
    <condition>Substance Use</condition>
    <condition>Pregnancy Related</condition>
    <condition>Narcotic-Related Disorders</condition>
    <condition>Buprenorphine Dependence</condition>
    <arm_group>
      <arm_group_label>Pregnant Mothers with Opioid Use Disorder</arm_group_label>
      <description>Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pregnant Mothers</arm_group_label>
      <description>Planned recruitment of 20 mothers who do not have any history of opioid use disorder.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Buprenorphine</intervention_name>
      <description>Pregnant mother must be taking Buprenorphine</description>
      <arm_group_label>Pregnant Mothers with Opioid Use Disorder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Maternal Brain MRI</intervention_name>
      <description>Maternal Brain MRI obtained between 24-32 week gestation</description>
      <arm_group_label>Pregnant Mothers</arm_group_label>
      <arm_group_label>Pregnant Mothers with Opioid Use Disorder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood Samples</intervention_name>
      <description>During the MRI visit blood samples will be drawn: one hour prior to MRI, immediately before MRI, and one hour post MRI to test for Buprenorphine levels.</description>
      <arm_group_label>Pregnant Mothers with Opioid Use Disorder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Participants will answer questionnaires about their medical history, pregnancy, and substance use.</description>
      <arm_group_label>Pregnant Mothers</arm_group_label>
      <arm_group_label>Pregnant Mothers with Opioid Use Disorder</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Biosamples:&#xD;
  &#xD;
        During the MRI visit blood samples will be collected to estimate steady-state plasma level of&#xD;
        buprenorphine using a population pharmacokinetic approach.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Any woman of the age of 18 or older that is having a single pregnancy, and currently taking&#xD;
          buprenorphine for opioid use disorder.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Pregnant Women with OUD&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: &gt;18 years old&#xD;
  &#xD;
            -  Any subject that is currently on Buprenorphine at time of screening&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Serious maternal medical illness&#xD;
  &#xD;
            -  HIV or AIDs&#xD;
  &#xD;
            -  Polysubstance use&#xD;
  &#xD;
            -  Score &gt;9 on the PHQ-9, and score &gt;0 on item 9 which is about suicidality&#xD;
  &#xD;
            -  Score of 8 or more on GAD-7&#xD;
  &#xD;
            -  Any contraindications for MRI&#xD;
  &#xD;
            -  Known or suspected major fetal congenital abnormalities&#xD;
  &#xD;
          Pregnant Women with no history of OUD&#xD;
  &#xD;
          Inclusion:&#xD;
  &#xD;
            -  Age: &gt;18 years old&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
          Exclusion:&#xD;
  &#xD;
            -  Serious maternal medical illness&#xD;
  &#xD;
            -  HIV or AIDS&#xD;
  &#xD;
            -  Score of &gt;9 on the PHQ-9, and a score of &gt;0 on item 9 which is about suicidality&#xD;
  &#xD;
            -  Score of 8 or more on GAD-7&#xD;
  &#xD;
            -  Known or suspected major fetal congenital abnormalities&#xD;
  &#xD;
            -  Any contraindications for MRI&#xD;
  &#xD;
            -  Opioid or polysubstance abuse as identified on urine screening&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rupa Radhakrishnan, MS, MD</last_name>
      <phone>(317) 963-0156</phone>
      <email>rradhak@iu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karlye Pinto, RN</last_name>
      <phone>317-963-8849</phone>
      <email>kapinto@iu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Riley Hospital for Children</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karlye Pinto, RN</last_name>
        <phone>317-963-8849</phone>
        <email>kapinto@iu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Brittany Yeley, RN</last_name>
        <email>bcyeley@iu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Rupa Radhakrishnan, MS, MD</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>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indiana University</investigator_affiliation>
      <investigator_full_name>Rupa Radhakrishnan</investigator_full_name>
      <investigator_title>Associate Professor of Radiology &amp; Imaging Sciences</investigator_title>
    </responsible_party>
    <keyword>Pregnant with Opioid Use Disorder</keyword>
    <keyword>Opioid Use Disorder</keyword>
    <keyword>Subutex</keyword>
    <keyword>Buprenorphine</keyword>
    <keyword>Pregnant taking buprenorphine/subutex</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
      <mesh_term>Opioid-Related Disorders</mesh_term>
      <mesh_term>Narcotic-Related Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Buprenorphine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06008990
  org study id: RADY-IIR-19466
  secondary id: 1R03DA056797-01A1
  nct id: NCT06008990
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study aims to learn more about opioid use disorder (OUD) during pregnancy and
        how outcomes for pregnant women and their newborns can be improved. During pregnancy, people
        with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested
        to know how the medication is broken down by the body during pregnancy and how effective it
        is. The investigators also want to learn if this medication and OUD have any effect on the
        different parts of the brain when compared to mothers without OUD.
  observational model: Cohort
  time perspective: Prospective
  measure: Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI.
  time frame: During MRI visit between 24-32 weeks gestational age
  measure: Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
  time frame: During MRI visit between 24-32 weeks gestational age
  measure: Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD.
  time frame: During MRI visit between 24-32 weeks gestational age
  measure: Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD.
  time frame: During MRI visit between 24-32 weeks gestational age
  measure: Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD
  time frame: During MRI visit between 24-32 weeks gestational age
  arm group label: Pregnant Mothers with Opioid Use Disorder
  description: Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
  arm group label: Pregnant Mothers
  description: Planned recruitment of 20 mothers who do not have any history of opioid use disorder.
  intervention type: Drug
  intervention name: Buprenorphine
  description: Pregnant mother must be taking Buprenorphine
  arm group label: Pregnant Mothers with Opioid Use Disorder
  intervention type: Diagnostic Test
  intervention name: Maternal Brain MRI
  description: Maternal Brain MRI obtained between 24-32 week gestation
  arm group label: Pregnant Mothers
  arm group label: Pregnant Mothers with Opioid Use Disorder
  intervention type: Other
  intervention name: Blood Samples
  description: During the MRI visit blood samples will be drawn: one hour prior to MRI, immediately before MRI, and one hour post MRI to test for Buprenorphine levels.
  arm group label: Pregnant Mothers with Opioid Use Disorder
  intervention type: Behavioral
  intervention name: Questionnaires
  description: Participants will answer questionnaires about their medical history, pregnancy, and substance use.
  arm group label: Pregnant Mothers
  arm group label: Pregnant Mothers with Opioid Use Disorder
  Biosamples:
  
        During the MRI visit blood samples will be collected to estimate steady-state plasma level of
        buprenorphine using a population pharmacokinetic approach.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rupa Radhakrishnan, MS, MD
  phone: (317) 963-0156
  email: rradhak@iu.edu
  last name: Karlye Pinto, RN
  phone: 317-963-8849
  email: kapinto@iu.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Indiana University
  investigator full name: Rupa Radhakrishnan
  investigator title: Associate Professor of Radiology & Imaging Sciences
  mesh term: Substance-Related Disorders
  mesh term: Opioid-Related Disorders
  mesh term: Narcotic-Related Disorders
  mesh term: Buprenorphine
  sharing ipd: Undecided