<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/NCT03285061</url>
  </required_header>
  <id_info>
    <org_study_id>2017P002031</org_study_id>
    <nct_id>NCT03285061</nct_id>
  </id_info>
  <brief_title>Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery</brief_title>
  <official_title>Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to survey the drug disposal methods of orthopedic foot and ankle patients&#xD;
      with excess pain medication following and operation. The study is a randomized control trial&#xD;
      comparing the use of FDA approved at home disposal methods to current clinical methods of&#xD;
      recommending disposal at medication drop off locations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Safely Disposed The Excess Medication</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Medication Disposal</condition>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Standard Disposal Instructions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At Home Disposal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deterra Drug Deactivation System</intervention_name>
    <description>A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.</description>
    <arm_group_label>At Home Disposal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This study will include foot and ankle orthopedic patients at Brigham and Women's&#xD;
             Hospital undergoing a surgical procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those under age 18 will be excluded from this study, as their variation in care could&#xD;
             affect the data. We will also exclude adults with impaired decision-making capacity&#xD;
             and adults who take methadone or have a history of prior opioid dependence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Chiodo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://deterrasystem.com/</url>
    <description>Deactivation System Website</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>November 13, 2020</results_first_submitted>
  <results_first_submitted_qc>January 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2021</results_first_posted>
  <last_update_submitted>January 3, 2021</last_update_submitted>
  <last_update_submitted_qc>January 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Christopher Chiodo</investigator_full_name>
    <investigator_title>Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers or organizations.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03285061/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03285061/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Disposal Instructions</title>
          <description>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
        </group>
        <group group_id="P2">
          <title>At Home Disposal</title>
          <description>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.&#xD;
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Disposal Instructions</title>
          <description>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
        </group>
        <group group_id="B2">
          <title>At Home Disposal</title>
          <description>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.&#xD;
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="38"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="38"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Safely Disposed The Excess Medication</title>
        <description>Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.</description>
        <time_frame>6 weeks</time_frame>
        <population>These two populations constitute a subgroup of all patients initially enrolled in the study.&#xD;
Specifically, these two populations constitute those patients that had leftover medications (as opposed to all patients who were enrolled in the trial).&#xD;
For this reason, these numbers are disparate from those of the Results Participant Flow.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Disposal Instructions</title>
            <description>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
          </group>
          <group group_id="O2">
            <title>At Home Disposal</title>
            <description>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.&#xD;
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Safely Disposed The Excess Medication</title>
          <description>Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.</description>
          <population>These two populations constitute a subgroup of all patients initially enrolled in the study.&#xD;
Specifically, these two populations constitute those patients that had leftover medications (as opposed to all patients who were enrolled in the trial).&#xD;
For this reason, these numbers are disparate from those of the Results Participant Flow.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>All-Cause Mortality and Serious Adverse Events were not monitored/assessed. This was a survey study with minimal risks. It was anticipated that the questionnaires had no affiliated risk of physical or emotional harm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Disposal Instructions</title>
          <description>These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.</description>
        </group>
        <group group_id="E2">
          <title>At Home Disposal</title>
          <description>With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.&#xD;
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Single site study: results may not be replicable in other settings or in patients undergoing other procedures&#xD;
Potential for reporting bias&#xD;
Patients may have felt social pressure to properly dispose of medication&#xD;
Since the time of this study, the FDA has conditionally endorsed flushing unused dangerous medications down the toilet in instances in which a take back location is not available.&#xD;
Amounts initially prescribed and leftover were not recorded</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Christopher Chiodo</name_or_title>
      <organization>Brigham &amp; Women's Hospital</organization>
      <phone>617-983-7363</phone>
      <email>cchiodo@bwh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03285061
org study id: 2017P002031
nct id: NCT03285061
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to survey the drug disposal methods of orthopedic foot and ankle patients
      with excess pain medication following and operation. The study is a randomized control trial
      comparing the use of FDA approved at home disposal methods to current clinical methods of
      recommending disposal at medication drop off locations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Number of Participants Who Safely Disposed The Excess Medication
time frame: 6 weeks
description: Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.
arm group label: Standard Disposal Instructions
arm group type: No Intervention
description: These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
arm group label: At Home Disposal
arm group type: Experimental
description: With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
intervention type: Device
intervention name: Deterra Drug Deactivation System
description: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
arm group label: At Home Disposal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Chiodo, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
url: http://deterrasystem.com/
description: Deactivation System Website
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Christopher Chiodo
investigator title: Attending Orthopedic Surgeon and Chief of the Foot and Ankle Service at the Brigham and Women's and Faulkner Hospitals
sharing ipd: No
ipd description: IPD will not be shared with other researchers or organizations.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Single site study: results may not be replicable in other settings or in patients undergoing other procedures
Potential for reporting bias
Patients may have felt social pressure to properly dispose of medication
Since the time of this study, the FDA has conditionally endorsed flushing unused dangerous medications down the toilet in instances in which a take back location is not available.
Amounts initially prescribed and leftover were not recorded
point of contact: 