<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/NCT03305497</url>
  </required_header>
  <id_info>
    <org_study_id>1705005398</org_study_id>
    <nct_id>NCT03305497</nct_id>
  </id_info>
  <brief_title>Piloting a Naloxone Intervention in Philadelphia</brief_title>
  <official_title>Piloting a Naloxone Intervention in an Emergency Response Community to Reduce Opioid Overdoes in Philadelphia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bar-Ilan University, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Drexel 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>
      The escalating opioid overdose epidemic is one of the most serious public health problems&#xD;
      confronting the U.S. Death due to drug overdose is a significant and rising cause of&#xD;
      mortality and morbidity in Philadelphia. While naloxone is increasingly accessible to combat&#xD;
      opioid overdoses, new responses to delivering naloxone to overdose events are needed. The&#xD;
      proposed pilot project, to be conducted in Philadelphia, will pursue three specific aims: 1)&#xD;
      Identify barriers and facilitators of acceptance and use of a smartphone-based naloxone&#xD;
      intervention; 2) Pilot test the implementation of the intervention among 55 non-medical&#xD;
      opioid users and 55 community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be&#xD;
      used in a subsequent R01 study to conduct a large-scale, multi-site implementation trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The escalating opioid overdose epidemic is one of the most serious public health problems&#xD;
      confronting the U.S. In 2014, a record 47,055 people died from a drug overdose in the U.S.,&#xD;
      which outnumbered deaths from motor vehicle crashes by approximately one and a half times.&#xD;
      Heroin and misuse of prescription opioids contributed to a majority of drug overdoses in&#xD;
      2014. Death due to drug overdose is a significant and rising cause of mortality and morbidity&#xD;
      in Philadelphia. In 2015, almost 700 drug overdose deaths were reported in Philadelphia -&#xD;
      twice as many as deaths from homicide. In response, health policy, legislation, and research&#xD;
      funding are increasingly converging in support of the distribution of naloxone, an opioid&#xD;
      antagonist, and community-based opioid overdose prevention programs (OPP). The success of OPP&#xD;
      is contingent upon the willingness and effectiveness of bystanders to respond to an overdose&#xD;
      event and administer naloxone. Emergency Response Communities (ERC) are specialized&#xD;
      smartphone-based social networks in which members are approved carriers and/or potential&#xD;
      users of a specific medication, such as naloxone. The ERC approach is ideally suited to&#xD;
      support, facilitate, and encourage naloxone administration in opioid overdose emergencies,&#xD;
      but is untested to date. The model combines GPS and IP-location tracking to identify&#xD;
      potential opioid overdose through a smartphone application or app. Towards this end, we are&#xD;
      proposing the development and pilot testing of a smartphone app-based naxolone intervention&#xD;
      (ERC-NAX) in an ERC in Philadelphia. Research is needed to understand the needs and barriers&#xD;
      in communities at high-risk for opioid overdose that will enable effective design, adaption,&#xD;
      and implementation of an ERC-NAX app. Guided by preliminary data from study investigators,&#xD;
      the proposed pilot project will pursue three specific aims: 1) Identify barriers and&#xD;
      facilitators of acceptance and use of a smartphone-based ERC naloxone intervention; 2) Pilot&#xD;
      test the implementation of ERC-NAX in an ERC consisting of 55 non-medical opioid users and 55&#xD;
      community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be used in a&#xD;
      subsequent R01 study to conduct a large-scale, multi-site implementation trial. This 3-year&#xD;
      study will provide actionable evidence regarding the viability and acceptance of an app-based&#xD;
      naloxone intervention following the ERC model. It will be developed and tested in partnership&#xD;
      with two community partners in Philadelphia with extensive experience in overdose prevention.&#xD;
      This proposed intervention is significant since it leverages the growing success of OPP and&#xD;
      will empower communities at high-risk for opioid overdose to provide rapid, secure, and&#xD;
      effective emergency response in the event of overdose. This novel intervention, which is&#xD;
      designed to augment emergency medical services in the rapid delivery of naloxone to overdose&#xD;
      victims, may be effective at deescalating the epidemic of opioid overdose fatalities in&#xD;
      Philadelphia and communities elsewhere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Use of mobile phone app</measure>
    <time_frame>One year</time_frame>
    <description>Will persons equipped with the mobile phone app signal overdoses and/or respond to overdoses when signaled.</description>
  </primary_outcome>
  <enrollment type="Actual">110</enrollment>
  <condition>Opioids; Harmful Use</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Phone Application</intervention_name>
    <description>110 persons will be equipped with a mobile phone application, trained in overdose prevention, and equipped with naloxone. The mobile phone app will allow persons witnessing an overdose to signal persons in the vicinity to respond with naloxone.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        55 non-medical users of opioids (NMOU) (e.g., prescription opioids, heroin) and 55&#xD;
        community members who know active, former, or deceased NMOU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Weekly misuse of heroin and/or rx opioid during past 30 days OR knows active, former, or&#xD;
        deceased NMOU 2. Currently lives in zip codes 19122, 19125, 19133, 19134 3. Willingness to&#xD;
        carry naloxone 4. Owns smartphone/data package 5. 18 years old or older 6. Speaks/reads&#xD;
        English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18&#xD;
&#xD;
          2. Does not speak/read English&#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>Stephen Lankenau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kensington</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Wagner KD, Davidson PJ, Iverson E, Washburn R, Burke E, Kral AH, McNeeley M, Jackson Bloom J, Lankenau SE. &quot;I felt like a superhero&quot;: the experience of responding to drug overdose among individuals trained in overdose prevention. Int J Drug Policy. 2014 Jan;25(1):157-65. doi: 10.1016/j.drugpo.2013.07.003. Epub 2013 Aug 9.</citation>
    <PMID>23932166</PMID>
  </results_reference>
  <results_reference>
    <citation>Silva K, Schrager SM, Kecojevic A, Lankenau SE. Factors associated with history of non-fatal overdose among young nonmedical users of prescription drugs. Drug Alcohol Depend. 2013 Feb 1;128(1-2):104-10. doi: 10.1016/j.drugalcdep.2012.08.014. Epub 2012 Sep 10.</citation>
    <PMID>22974490</PMID>
  </results_reference>
  <results_reference>
    <citation>Lankenau SE, Wagner KD, Silva K, Kecojevic A, Iverson E, McNeely M, Kral AH. Injection drug users trained by overdose prevention programs: responses to witnessed overdoses. J Community Health. 2013 Feb;38(1):133-41. doi: 10.1007/s10900-012-9591-7.</citation>
    <PMID>22847602</PMID>
  </results_reference>
  <results_reference>
    <citation>Lankenau SE, Walley A. Opioids and deaths. N Engl J Med. 2011 Feb 17;364(7):686. doi: 10.1056/NEJMc1014490. No abstract available.</citation>
    <PMID>21323558</PMID>
  </results_reference>
  <results_reference>
    <citation>Wagner KD, Iverson E, Wong CF, Bloom JJ, McNeeley M, Davidson PJ, McCarty C, Kral AH, Lankenau SE. Personal social network factors associated with overdose prevention training participation. Subst Use Misuse. 2013 Jan;48(1-2):21-30. doi: 10.3109/10826084.2012.720335. Epub 2012 Sep 19.</citation>
    <PMID>22988840</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid Overdose; Naloxone</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03305497/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03305497
org study id: 1705005398
nct id: NCT03305497
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The escalating opioid overdose epidemic is one of the most serious public health problems
      confronting the U.S. Death due to drug overdose is a significant and rising cause of
      mortality and morbidity in Philadelphia. While naloxone is increasingly accessible to combat
      opioid overdoses, new responses to delivering naloxone to overdose events are needed. The
      proposed pilot project, to be conducted in Philadelphia, will pursue three specific aims: 1)
      Identify barriers and facilitators of acceptance and use of a smartphone-based naloxone
      intervention; 2) Pilot test the implementation of the intervention among 55 non-medical
      opioid users and 55 community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be
      used in a subsequent R01 study to conduct a large-scale, multi-site implementation trial.
The escalating opioid overdose epidemic is one of the most serious public health problems
      confronting the U.S. In 2014, a record 47,055 people died from a drug overdose in the U.S.,
      which outnumbered deaths from motor vehicle crashes by approximately one and a half times.
      Heroin and misuse of prescription opioids contributed to a majority of drug overdoses in
      2014. Death due to drug overdose is a significant and rising cause of mortality and morbidity
      in Philadelphia. In 2015, almost 700 drug overdose deaths were reported in Philadelphia -
      twice as many as deaths from homicide. In response, health policy, legislation, and research
      funding are increasingly converging in support of the distribution of naloxone, an opioid
      antagonist, and community-based opioid overdose prevention programs (OPP). The success of OPP
      is contingent upon the willingness and effectiveness of bystanders to respond to an overdose
      event and administer naloxone. Emergency Response Communities (ERC) are specialized
      smartphone-based social networks in which members are approved carriers and/or potential
      users of a specific medication, such as naloxone. The ERC approach is ideally suited to
      support, facilitate, and encourage naloxone administration in opioid overdose emergencies,
      but is untested to date. The model combines GPS and IP-location tracking to identify
      potential opioid overdose through a smartphone application or app. Towards this end, we are
      proposing the development and pilot testing of a smartphone app-based naxolone intervention
      (ERC-NAX) in an ERC in Philadelphia. Research is needed to understand the needs and barriers
      in communities at high-risk for opioid overdose that will enable effective design, adaption,
      and implementation of an ERC-NAX app. Guided by preliminary data from study investigators,
      the proposed pilot project will pursue three specific aims: 1) Identify barriers and
      facilitators of acceptance and use of a smartphone-based ERC naloxone intervention; 2) Pilot
      test the implementation of ERC-NAX in an ERC consisting of 55 non-medical opioid users and 55
      community members; 3) Synthesize knowledge acquired in Aims 1 and 2 to be used in a
      subsequent R01 study to conduct a large-scale, multi-site implementation trial. This 3-year
      study will provide actionable evidence regarding the viability and acceptance of an app-based
      naloxone intervention following the ERC model. It will be developed and tested in partnership
      with two community partners in Philadelphia with extensive experience in overdose prevention.
      This proposed intervention is significant since it leverages the growing success of OPP and
      will empower communities at high-risk for opioid overdose to provide rapid, secure, and
      effective emergency response in the event of overdose. This novel intervention, which is
      designed to augment emergency medical services in the rapid delivery of naloxone to overdose
      victims, may be effective at deescalating the epidemic of opioid overdose fatalities in
      Philadelphia and communities elsewhere.
observational model: Ecologic or Community
time perspective: Prospective
measure: Use of mobile phone app
time frame: One year
description: Will persons equipped with the mobile phone app signal overdoses and/or respond to overdoses when signaled.
intervention type: Behavioral
intervention name: Mobile Phone Application
description: 110 persons will be equipped with a mobile phone application, trained in overdose prevention, and equipped with naloxone. The mobile phone app will allow persons witnessing an overdose to signal persons in the vicinity to respond with naloxone.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Lankenau, PhD
role: Principal Investigator
affiliation: Drexel University
facility: 
country: United States
citation: Wagner KD, Davidson PJ, Iverson E, Washburn R, Burke E, Kral AH, McNeeley M, Jackson Bloom J, Lankenau SE. "I felt like a superhero": the experience of responding to drug overdose among individuals trained in overdose prevention. Int J Drug Policy. 2014 Jan;25(1):157-65. doi: 10.1016/j.drugpo.2013.07.003. Epub 2013 Aug 9.
PMID: 23932166
citation: Silva K, Schrager SM, Kecojevic A, Lankenau SE. Factors associated with history of non-fatal overdose among young nonmedical users of prescription drugs. Drug Alcohol Depend. 2013 Feb 1;128(1-2):104-10. doi: 10.1016/j.drugalcdep.2012.08.014. Epub 2012 Sep 10.
PMID: 22974490
citation: Lankenau SE, Wagner KD, Silva K, Kecojevic A, Iverson E, McNeely M, Kral AH. Injection drug users trained by overdose prevention programs: responses to witnessed overdoses. J Community Health. 2013 Feb;38(1):133-41. doi: 10.1007/s10900-012-9591-7.
PMID: 22847602
citation: Lankenau SE, Walley A. Opioids and deaths. N Engl J Med. 2011 Feb 17;364(7):686. doi: 10.1056/NEJMc1014490. No abstract available.
PMID: 21323558
citation: Wagner KD, Iverson E, Wong CF, Bloom JJ, McNeeley M, Davidson PJ, McCarty C, Kral AH, Lankenau SE. Personal social network factors associated with overdose prevention training participation. Subst Use Misuse. 2013 Jan;48(1-2):21-30. doi: 10.3109/10826084.2012.720335. Epub 2012 Sep 19.
PMID: 22988840
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan to share IPD with other researchers.
provided document: 