<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/NCT03254043</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00145200</org_study_id>
    <secondary_id>R34DA042926-01A1</secondary_id>
    <nct_id>NCT03254043</nct_id>
  </id_info>
  <brief_title>Evaluating a Novel Medication Device for Methadone Dosing</brief_title>
  <official_title>Evaluating a Novel Medication Device for Methadone Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</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 will evaluate whether a commercially available, secure, electronic pill box is a&#xD;
      feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for&#xD;
      both methadone clinic patients and staff members.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant willingness to use the MedMinder &quot;Jon&quot; electronic pillbox to manage take-home doses of methadone</measure>
    <time_frame>Week 12</time_frame>
    <description>Feasibility will be assessed by conducting a survival analysis of participant retention in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant acceptance of the MedMinder &quot;Jon&quot; electronic pillbox to manage take-home doses of methadone</measure>
    <time_frame>Week 9</time_frame>
    <description>Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in participant satisfaction</measure>
    <time_frame>Week 4</time_frame>
    <description>Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder &quot;Jon&quot; electronic pillbox phase as a measure of change in participant satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in participant satisfaction</measure>
    <time_frame>Week 8</time_frame>
    <description>Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder &quot;Jon&quot; electronic pillbox phase as a measure of change in participant satisfaction.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment-as-Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will routine methadone clinic care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Take-home Dosing using MedMinder &quot;Jon&quot; Electronic Pill Box</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 50% of their methadone dose in the morning in the clinic and 50% of their dose will be dispensed in an electronic pill box for participants to take at home later that day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice Phase</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be allowed to select one final Treatment-As-Usual or the MedMinder &quot;Jon&quot; Electronic Pill Box for the final phase of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Take-home Dosing Procedures</intervention_name>
    <description>Within-subject evaluation across 2 phases with a final choice condition</description>
    <arm_group_label>Choice Phase</arm_group_label>
    <arm_group_label>Take-home Dosing using MedMinder &quot;Jon&quot; Electronic Pill Box</arm_group_label>
    <arm_group_label>Treatment-as-Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Receiving methadone for the treatment of opioid use disorder for at least 90 days and&#xD;
             having been on the same methadone dose for at least 30 days&#xD;
&#xD;
          -  Have previously received a take-home dose of methadone as part of routine care&#xD;
&#xD;
          -  Be willing to comply with the study schedule&#xD;
&#xD;
          -  Be a methadone patient in the clinic within which this study is being conducted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of an acute medical problems that requires immediate or intense medical&#xD;
             management&#xD;
&#xD;
          -  Presence of serious or unstable mental illness that interferes with study procedures&#xD;
&#xD;
          -  Planning to leave methadone treatment within the next 12 weeks&#xD;
&#xD;
          -  Being maintained on a dose of methadone that is less than 10mg or more than 100mg&#xD;
&#xD;
          -  Currently receiving split doses of methadone as part of routine care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Dunn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addiction Treatment Services (ATS)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</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>Opioid-Related Disorders</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/NCT03254043
org study id: IRB00145200
secondary id: R34DA042926-01A1
nct id: NCT03254043
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate whether a commercially available, secure, electronic pill box is a
      feasible, acceptable, and satisfactory method to manage take-home dosing of methadone for
      both methadone clinic patients and staff members.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Participant willingness to use the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
time frame: Week 12
description: Feasibility will be assessed by conducting a survival analysis of participant retention in the study
measure: Participant acceptance of the MedMinder "Jon" electronic pillbox to manage take-home doses of methadone
time frame: Week 9
description: Percent of participants who select the Electronic Pill Box during their Choice phase (phase 3)
measure: Change in participant satisfaction
time frame: Week 4
description: Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder "Jon" electronic pillbox phase as a measure of change in participant satisfaction.
measure: Change in participant satisfaction
time frame: Week 8
description: Participant satisfaction will be assessed using the Client Satisfaction Questionnaire- an 8-item self-report measure on which patients will rate their satisfaction with treatment on a 4-item Likert scale. Values will be summed for a total satisfaction rating (range 8-32), with higher scores indicating greater satisfaction. Participants will complete the CSQ at week 4 and week 8, and the CSQ ratings from the treatment-as-usual will be subtracted from the ratings following the MedMinder "Jon" electronic pillbox phase as a measure of change in participant satisfaction.
arm group label: Treatment-as-Usual
arm group type: Active Comparator
description: Participants will routine methadone clinic care.
arm group label: Take-home Dosing using MedMinder "Jon" Electronic Pill Box
arm group type: Experimental
description: Participants will receive 50% of their methadone dose in the morning in the clinic and 50% of their dose will be dispensed in an electronic pill box for participants to take at home later that day.
arm group label: Choice Phase
arm group type: Other
description: Participants will be allowed to select one final Treatment-As-Usual or the MedMinder "Jon" Electronic Pill Box for the final phase of the study.
intervention type: Behavioral
intervention name: Take-home Dosing Procedures
description: Within-subject evaluation across 2 phases with a final choice condition
arm group label: Choice Phase
arm group label: Take-home Dosing using MedMinder "Jon" Electronic Pill Box
arm group label: Treatment-as-Usual
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kelly Dunn, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: No