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/NCT05991687</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00236974</org_study_id>
      <secondary_id>E20233700-001</secondary_id>
      <nct_id>NCT05991687</nct_id>
    </id_info>
    <brief_title>Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination</brief_title>
    <acronym>MEDSAFE</acronym>
    <official_title>Methods for Effective Disposal of Surplus Analgesics to Facilitate Elimination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Michigan Department of Health and Human Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home&#xD;
        disposal methods for leftover prescription opioids after discharge from surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Use of assigned disposal method</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>Among patients who have leftover opioids, patient report of the use of their assigned mail-in or in-home method of disposal by 2 weeks after surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Use of safe disposal method</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>Patient-reported use of a method for disposal of leftover opioids that includes mail-in, in-home, pharmacy drop off, or flushing down the toilet by</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of any disposal method</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>Patient-reported use of any method to dispose of leftover opioids, that includes assigned methods, safe methods, and other methods such as placing in the trash</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of Intervention Measure (FIM)</measure>
      <time_frame>2 weeks after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention Measure (AIM)</measure>
      <time_frame>2 weeks after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-Reported Satisfaction with Use of Disposal Method (study derived question)</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>Patient report of overall satisfaction with use of the assigned disposal method, on a 0 (worst) to 10 (best) numeric scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Surgery</condition>
    <condition>Analgesics, Opioids</condition>
    <arm_group>
      <arm_group_label>In-home</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Mail-in</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>In-home drug disposal pouch</intervention_name>
      <description>Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.</description>
      <arm_group_label>In-home</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mail-in prepaid envelope</intervention_name>
      <description>Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery</description>
      <arm_group_label>Mail-in</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Anticipated to be prescribed and use an opioid medication to treat acute pain after&#xD;
               elective outpatient surgery&#xD;
  &#xD;
            -  Opioid-naive&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to receive email and/or phone calls for follow up assessment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mar Bicket, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Lipkovitch</last_name>
      <phone>734-936-4280</phone>
      <email>hlipkovi@umich.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Heather Lipkovitch</last_name>
        <phone>734-936-4280</phone>
        <email>hlipkovi@umich.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Mark Bicket, MD, PhD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Opioids</keyword>
    <keyword>Drug disposal</keyword>
    <!-- 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/NCT05991687
  org study id: HUM00236974
  secondary id: E20233700-001
  nct id: NCT05991687
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective is to evaluate the difference in outcomes for mail-in vs. in-home
        disposal methods for leftover prescription opioids after discharge from surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Use of assigned disposal method
  time frame: 2 weeks after surgery
  description: Among patients who have leftover opioids, patient report of the use of their assigned mail-in or in-home method of disposal by 2 weeks after surgery.
  measure: Use of safe disposal method
  time frame: 2 weeks after surgery
  description: Patient-reported use of a method for disposal of leftover opioids that includes mail-in, in-home, pharmacy drop off, or flushing down the toilet by
  measure: Use of any disposal method
  time frame: 2 weeks after surgery
  description: Patient-reported use of any method to dispose of leftover opioids, that includes assigned methods, safe methods, and other methods such as placing in the trash
  measure: Feasibility of Intervention Measure (FIM)
  time frame: 2 weeks after surgery
  measure: Acceptability of Intervention Measure (AIM)
  time frame: 2 weeks after surgery
  measure: Patient-Reported Satisfaction with Use of Disposal Method (study derived question)
  time frame: 2 weeks after surgery
  description: Patient report of overall satisfaction with use of the assigned disposal method, on a 0 (worst) to 10 (best) numeric scale
  arm group label: In-home
  arm group type: Active Comparator
  arm group label: Mail-in
  arm group type: Active Comparator
  intervention type: Other
  intervention name: In-home drug disposal pouch
  description: Will receive a drug disposal pouch to inactivate leftover prescription opioids for disposal after surgery.
  arm group label: In-home
  intervention type: Other
  intervention name: Mail-in prepaid envelope
  description: Will receive a prepaid envelope to mail leftover prescription opioids for disposal after surgery
  arm group label: Mail-in
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mar Bicket, MD, PhD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Heather Lipkovitch
  phone: 734-936-4280
  email: hlipkovi@umich.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Mark Bicket, MD, PhD
  investigator title: Assistant Professor