<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/NCT03752411</url>
  </required_header>
  <id_info>
    <org_study_id>18-0022</org_study_id>
    <nct_id>NCT03752411</nct_id>
  </id_info>
  <brief_title>Environment Analysis Inside an Investigational Prescription Bottle</brief_title>
  <official_title>The Use of Nomi Technology to Monitor Opioid Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test a research prescription bottle that will monitor the&#xD;
      physical environment inside the bottle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to test a research prescription bottle that will monitor the&#xD;
      physical environment inside the bottle. The participant will be asked to keep the medication&#xD;
      in the bottle and to remove each pill immediately before taking it.&#xD;
&#xD;
      The participant will not store medications in pill organizers, other pill bottles, pockets,&#xD;
      purses, etc. The participant will keep a record of when the participant removes a pill from&#xD;
      the bottle and takes it. Certain aspects of this study will be withheld from the participant&#xD;
      to preserve the integrity of the study. This information will be revealed at the conclusion&#xD;
      of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">November 5, 2023</completion_date>
  <primary_completion_date type="Actual">November 5, 2022</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>total medication dose</measure>
    <time_frame>day 90</time_frame>
    <description>pain medication dose (mg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total Pain scale</measure>
    <time_frame>day 90</time_frame>
    <description>On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total nausea scale</measure>
    <time_frame>day 90</time_frame>
    <description>On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total vomiting scale</measure>
    <time_frame>day 90</time_frame>
    <description>On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total sedation scale</measure>
    <time_frame>day 90</time_frame>
    <description>On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total bowel movements</measure>
    <time_frame>day 90</time_frame>
    <description>number of bowel movements (whole number)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total type of bowel movement</measure>
    <time_frame>day 90</time_frame>
    <description>choose one of the following: hard, soft, loose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall satisfaction with pain control</measure>
    <time_frame>day 90</time_frame>
    <description>0-10 scale where 0 is dissatisfied and 10 is very satisfied</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>opioid related behavior in treatment questionnaire</measure>
    <time_frame>day 90</time_frame>
    <description>Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prescribed opioids difficulty scale</measure>
    <time_frame>day 90</time_frame>
    <description>measures opioid management score (number 0-32) where 0-10 is low difficulty, 11-21 is moderate difficulty and 22-32 is high levels of difficulty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barretts impulsivity questionnaire</measure>
    <time_frame>day 90</time_frame>
    <description>Measures impulsivity behavior core (number 0-120) where 0-40 is low levels of impulsivity, 41-80 is moderate levels of impulsivity, and 81-120 is high levels of impulsivity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Research Bottle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will have medication dispensed in a research bottle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular prescription Bottle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will have medication dispensed in a regular prescription bottle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Research Bottle</intervention_name>
    <description>The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.</description>
    <arm_group_label>Research Bottle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular prescription Bottle</intervention_name>
    <description>This will test if the research bottle changes behavior relative to the research bottle</description>
    <arm_group_label>Regular prescription Bottle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic pain &gt; 3 months duration&#xD;
&#xD;
          -  major source of pain is due to low back pain diagnosis&#xD;
&#xD;
          -  prescribed only one type of opioid: hydrocodone 10mg/325 mg acetaminophen&#xD;
&#xD;
          -  Last urine drug study was done between 6-12 months ago&#xD;
&#xD;
          -  will have a return to clinic visit in 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent use of other opioids&#xD;
&#xD;
          -  use of intrathecal device&#xD;
&#xD;
          -  use of spinal cord stimulator&#xD;
&#xD;
          -  presence of pain due to cancer, chemotherapy, radiation treatment and/or cancer&#xD;
             related surgery&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  illiteracy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denise Wilkes, MD-PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.</citation>
    <PMID>25912277</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic 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>


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/NCT03752411
org study id: 18-0022
nct id: NCT03752411
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of the study is to test a research prescription bottle that will monitor the
      physical environment inside the bottle.
The purpose of the study is to test a research prescription bottle that will monitor the
      physical environment inside the bottle. The participant will be asked to keep the medication
      in the bottle and to remove each pill immediately before taking it.

      The participant will not store medications in pill organizers, other pill bottles, pockets,
      purses, etc. The participant will keep a record of when the participant removes a pill from
      the bottle and takes it. Certain aspects of this study will be withheld from the participant
      to preserve the integrity of the study. This information will be revealed at the conclusion
      of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Care Provider)
measure: total medication dose
time frame: day 90
description: pain medication dose (mg)
measure: total Pain scale
time frame: day 90
description: On a scale of 0-10 where 0 is no pain and 10 is the worst pain ever felt.
measure: total nausea scale
time frame: day 90
description: On a scale of 0-3 where 0=no nausea, 1= mild, 2= moderate, and 3= severe
measure: total vomiting scale
time frame: day 90
description: On a scale of 0-3 where 0=no vomiting, 1= mild, 2= moderate, and 3= severe
measure: total sedation scale
time frame: day 90
description: On a scale of 0-3 where 0=no sedation, 1= mild, 2= moderate, and 3= severe
measure: total bowel movements
time frame: day 90
description: number of bowel movements (whole number)
measure: total type of bowel movement
time frame: day 90
description: choose one of the following: hard, soft, loose
measure: overall satisfaction with pain control
time frame: day 90
description: 0-10 scale where 0 is dissatisfied and 10 is very satisfied
measure: opioid related behavior in treatment questionnaire
time frame: day 90
description: Measures opioid misuse score (number 0-40) where 0-10 is low misuse, 11-30 is moderate misuse and 31-40 is high misuse
measure: prescribed opioids difficulty scale
time frame: day 90
description: measures opioid management score (number 0-32) where 0-10 is low difficulty, 11-21 is moderate difficulty and 22-32 is high levels of difficulty
measure: Barretts impulsivity questionnaire
time frame: day 90
description: Measures impulsivity behavior core (number 0-120) where 0-40 is low levels of impulsivity, 41-80 is moderate levels of impulsivity, and 81-120 is high levels of impulsivity
arm group label: Research Bottle
arm group type: Experimental
description: This group will have medication dispensed in a research bottle.
arm group label: Regular prescription Bottle
arm group type: Placebo Comparator
description: This group will have medication dispensed in a regular prescription bottle
intervention type: Other
intervention name: Research Bottle
description: The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
arm group label: Research Bottle
intervention type: Other
intervention name: Regular prescription Bottle
description: This will test if the research bottle changes behavior relative to the research bottle
arm group label: Regular prescription Bottle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Denise Wilkes, MD-PhD
role: Study Director
affiliation: University of Texas
facility: 
country: United States
citation: Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.
PMID: 25912277
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No