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/NCT05966129</url>
    </required_header>
    <id_info>
      <org_study_id>PRO00104948_A</org_study_id>
      <secondary_id>U01HG010225</secondary_id>
      <nct_id>NCT05966129</nct_id>
    </id_info>
    <brief_title>A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Acute Pain Trial)</brief_title>
    <acronym>ADOPT PGx</acronym>
    <official_title>A Depression and Opioid Pragmatic Trial in Pharmacogenetics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Human Genome Research Institute (NHGRI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</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 study is comprised of three separate pharmacogenetic trials grouped into a single&#xD;
        protocol due to similarities in the intervention, the hypotheses, and the trial design. The&#xD;
        three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial.&#xD;
        Participants can enroll in only one of the three trials. All three trials were registered on&#xD;
        ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was&#xD;
        registered under a separate NCT# and NCT04445792 was converted to a screening record per&#xD;
        recent guidance on master protocol research programs (MPRPs). This record is specific to the&#xD;
        Acute Pain Trial within the ADOPT-PGx protocol.&#xD;
  &#xD;
        The Acute Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial.&#xD;
        Participants meeting eligibility criteria will be randomly assigned to either immediate&#xD;
        pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm)&#xD;
        or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators&#xD;
        will test the hypothesis that pharmacogenetic testing and genotype guided pain management&#xD;
        therapy improves pain control after surgery in participants who's body processes some pain&#xD;
        medicines slower than normal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pain and depression are conditions that impact substantial proportions of the US population.&#xD;
        Finding safe and effective drug therapies for both conditions is challenging. In the case of&#xD;
        treatment for acute and chronic pain, the challenge is finding effective therapy while&#xD;
        minimizing adverse effects or opioid addiction (and the ensuing consequences). For&#xD;
        depression, there are few clinically relevant predictors of successful treatment leading to&#xD;
        multiple trials of inadequate therapy for some patients. Both opioid and antidepressant&#xD;
        prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from&#xD;
        the Clinical Pharmacogenetics Implementation Consortium (CPIC).&#xD;
  &#xD;
        This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided&#xD;
        pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic&#xD;
        setting.&#xD;
  &#xD;
        The rationale for examining a genotype-guided approach to acute and chronic pain management&#xD;
        is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and&#xD;
        hydrocodone and data from a pilot study supporting improved pain control in intermediate and&#xD;
        poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline.&#xD;
        Similarly, the rationale for examining a genotype-guided approach to depression medication&#xD;
        therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19&#xD;
        oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials&#xD;
        support the hypothesis of improved depression symptom control in a genotype-guided arm.&#xD;
  &#xD;
        Study objectives:&#xD;
  &#xD;
        Determine if a genotype-guided approach to acute post-surgical pain therapy leads to improved&#xD;
        pain control compared to usual care, as defined by a decrease in the SIA score. Secondarily,&#xD;
        The investigators will evaluate whether this approach leads to reduced use of DEA Schedule II&#xD;
        opioids and reduced pain intensity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 10, 2021</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>10 Day SIA Score Change from Baseline</measure>
      <time_frame>Day of Surgery to 10 days post surgery</time_frame>
      <description>A composite measure of pain and opioid usage, the Silverman Integrated Analgesic Assessment (SIA) score, at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>10 Day Pain Intensity Change from Baseline</measure>
      <time_frame>10 days post-surgery</time_frame>
      <description>PROMIS Numeric Pain Rating Scale Pain intensity at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-surgery Opioid Usage Change from Baseline</measure>
      <time_frame>day of surgery through 10 days post-surgery</time_frame>
      <description>Opioid usage from surgery to10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 Month Prescription Pain Medication Misuse Change from Baseline</measure>
      <time_frame>3 months post surgery</time_frame>
      <description>PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1 Month Mobility Score Change from Baseline</measure>
      <time_frame>1 month post surgery</time_frame>
      <description>PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid Persistence Change from Baseline</measure>
      <time_frame>3-6 months post-surgery</time_frame>
      <description>Opioid persistence defined as a filled prescription for an opioid medication 3-6 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2004</enrollment>
    <condition>Acute Pain</condition>
    <arm_group>
      <arm_group_label>Acute Pain - Immediate PGx Testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Acute Pain - Delayed PGx Testing</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pharmacogenetic testing</intervention_name>
      <description>Genetic testing of CYP2D6 and CYP2C19</description>
      <arm_group_label>Acute Pain - Delayed PGx Testing</arm_group_label>
      <arm_group_label>Acute Pain - Immediate PGx Testing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical decisions support</intervention_name>
      <description>Prescribing recommendations to the provider based on the pharmacogenetic testing results</description>
      <arm_group_label>Acute Pain - Immediate PGx Testing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Acute Pain Trial&#xD;
  &#xD;
            -  Age ≥ 8 years&#xD;
  &#xD;
            -  English speaking or Spanish speaking&#xD;
  &#xD;
            -  Elective/planned surgery types with planned or anticipated to be treated with&#xD;
               tramadol, hydrocodone, or codeine pain management at an enrolling site, which may&#xD;
               include orthopedic surgeries (e.g. arthroplasty, spine, etc.), open abdominal surgery,&#xD;
               or cardiothoracic surgery and others&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          Trial-wide:&#xD;
  &#xD;
            -  Life expectancy less than 12 months&#xD;
  &#xD;
            -  Are too cognitively impaired to provide informed consent and/or complete study&#xD;
               protocol&#xD;
  &#xD;
            -  Are institutionalized or too ill to participate (i.e. mental or nursing home facility&#xD;
               or incarcerated)&#xD;
  &#xD;
            -  Have a history of allogeneic stem cell transplant or liver transplant&#xD;
  &#xD;
            -  People with prior clinical pharmacogenetic test results for genes relevant for the&#xD;
               study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for&#xD;
               depression) or already enrolled in an ADOPT PGx trial&#xD;
  &#xD;
          Acute Pain Trial&#xD;
  &#xD;
            -  Undergoing a laparoscopic surgery&#xD;
  &#xD;
            -  Receiving chronic opioid therapy, defined as use of opioids on most days for &gt;3 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hrishikesh Chakraborty</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kady-Ann Steen-Burrell</last_name>
      <phone>919-530-9711</phone>
      <email>kady.ann.steen.burrell@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Wilmington</city>
          <state>Delaware</state>
          <zip>19803</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, Pharm D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Florida - Gainesville</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32610</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Larisa Cavallari, MD</last_name>
        <phone>352-273-8245</phone>
        <email>lcavallari@cop.ufl.edu</email>
      </contact>
      <investigator>
        <last_name>Larisa Cavallari, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, PharmD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32827</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, PharmD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Indiana University</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Todd Skaar, MD</last_name>
        <phone>317-460-9748</phone>
        <email>tskaar@iu.edu</email>
      </contact>
      <investigator>
        <last_name>Todd Skaar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Deepak Voora, MD</last_name>
        <phone>919-684-6266</phone>
        <email>deepak.voora@duke.edu</email>
      </contact>
      <investigator>
        <last_name>Deepak Voora, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sanford Health</name>
        <address>
          <city>Fargo</city>
          <state>North Dakota</state>
          <zip>58104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lindsey Hines, MD</last_name>
        <phone>701-234-4036</phone>
        <email>Lindsay.Hines@SanfordHealth.org</email>
      </contact>
      <investigator>
        <last_name>Lindsey Hines, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Meharry Medical College</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rajbir Singh, MD</last_name>
        <phone>615-327-6204</phone>
        <email>rsingh@mmc.edu</email>
      </contact>
      <investigator>
        <last_name>Rajbir Singh, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nashville General Hospital</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rajbir Singh, MD</last_name>
        <phone>615-327-6204</phone>
        <email>rsingh@mmc.edu</email>
      </contact>
      <investigator>
        <last_name>Rajbir Singh, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Vanderbilt University Medical Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37232</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Peterson, MD</last_name>
        <phone>615-875-1404</phone>
        <email>josh.peterson@vumc.org</email>
      </contact>
      <investigator>
        <last_name>Josh Peterson, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacogenetic</keyword>
    <keyword>CYP2D6</keyword>
    <keyword>CYP2C19</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05966129
  org study id: PRO00104948_A
  secondary id: U01HG010225
  nct id: NCT05966129
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is comprised of three separate pharmacogenetic trials grouped into a single
        protocol due to similarities in the intervention, the hypotheses, and the trial design. The
        three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial.
        Participants can enroll in only one of the three trials. All three trials were registered on
        ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was
        registered under a separate NCT# and NCT04445792 was converted to a screening record per
        recent guidance on master protocol research programs (MPRPs). This record is specific to the
        Acute Pain Trial within the ADOPT-PGx protocol.
  
        The Acute Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial.
        Participants meeting eligibility criteria will be randomly assigned to either immediate
        pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm)
        or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators
        will test the hypothesis that pharmacogenetic testing and genotype guided pain management
        therapy improves pain control after surgery in participants who's body processes some pain
        medicines slower than normal.
  Pain and depression are conditions that impact substantial proportions of the US population.
        Finding safe and effective drug therapies for both conditions is challenging. In the case of
        treatment for acute and chronic pain, the challenge is finding effective therapy while
        minimizing adverse effects or opioid addiction (and the ensuing consequences). For
        depression, there are few clinically relevant predictors of successful treatment leading to
        multiple trials of inadequate therapy for some patients. Both opioid and antidepressant
        prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from
        the Clinical Pharmacogenetics Implementation Consortium (CPIC).
  
        This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided
        pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic
        setting.
  
        The rationale for examining a genotype-guided approach to acute and chronic pain management
        is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and
        hydrocodone and data from a pilot study supporting improved pain control in intermediate and
        poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline.
        Similarly, the rationale for examining a genotype-guided approach to depression medication
        therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19
        oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials
        support the hypothesis of improved depression symptom control in a genotype-guided arm.
  
        Study objectives:
  
        Determine if a genotype-guided approach to acute post-surgical pain therapy leads to improved
        pain control compared to usual care, as defined by a decrease in the SIA score. Secondarily,
        The investigators will evaluate whether this approach leads to reduced use of DEA Schedule II
        opioids and reduced pain intensity.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 10 Day SIA Score Change from Baseline
  time frame: Day of Surgery to 10 days post surgery
  description: A composite measure of pain and opioid usage, the Silverman Integrated Analgesic Assessment (SIA) score, at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
  measure: 10 Day Pain Intensity Change from Baseline
  time frame: 10 days post-surgery
  description: PROMIS Numeric Pain Rating Scale Pain intensity at 10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
  measure: Post-surgery Opioid Usage Change from Baseline
  time frame: day of surgery through 10 days post-surgery
  description: Opioid usage from surgery to10 days post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
  measure: 3 Month Prescription Pain Medication Misuse Change from Baseline
  time frame: 3 months post surgery
  description: PROMIS prescription pain medication misuse T-scores at 3 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
  measure: 1 Month Mobility Score Change from Baseline
  time frame: 1 month post surgery
  description: PROMIS mobility score at 1 month post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75.
  measure: Opioid Persistence Change from Baseline
  time frame: 3-6 months post-surgery
  description: Opioid persistence defined as a filled prescription for an opioid medication 3-6 months post-surgery in participants who have a genotypic or pheno-converted CYP2D6 activity score ≤ 0.75
  arm group label: Acute Pain - Immediate PGx Testing
  arm group type: Experimental
  description: Immediate genetic testing of CYP2D6 and clinical decisions support for pain management prescribing to the healthcare provider
  arm group label: Acute Pain - Delayed PGx Testing
  arm group type: Other
  description: Delayed genetic testing of CYP2D6 and return of results after the conclusion of the 6-month follow-up period
  intervention type: Other
  intervention name: Pharmacogenetic testing
  description: Genetic testing of CYP2D6 and CYP2C19
  arm group label: Acute Pain - Delayed PGx Testing
  arm group label: Acute Pain - Immediate PGx Testing
  intervention type: Other
  intervention name: Clinical decisions support
  description: Prescribing recommendations to the provider based on the pharmacogenetic testing results
  arm group label: Acute Pain - Immediate PGx Testing
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hrishikesh Chakraborty
  role: Principal Investigator
  affiliation: Duke University
  last name: Kady-Ann Steen-Burrell
  phone: 919-530-9711
  email: kady.ann.steen.burrell@duke.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Acute Pain
  sharing ipd: No