<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/NCT04449744</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00038163 - Pilot</org_study_id>
    <secondary_id>R01CE003039</secondary_id>
    <nct_id>NCT04449744</nct_id>
  </id_info>
  <brief_title>Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study</brief_title>
  <official_title>Effects of Remote Motivational Enhancement &amp; MySafeRx on Post-Detox Engagement and Retention in Buprenorphine Treatment (MySafeRx) - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge Health Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</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>
      Opioid overdoses are a significant problem nationwide and novel interventions that can&#xD;
      prevent overdose by improving buprenorphine treatment for opioid use disorder are a public&#xD;
      health priority. This study will both investigate the effects of starting remote motivational&#xD;
      enhancement during inpatient detoxification on rates of engagement in Buprenorphine/ Naloxone&#xD;
      (B/N) treatment and evaluate the impact of MySafeRx, a mobile device application which&#xD;
      integrates remote motivational coaching with daily observed dosing from secure electronic&#xD;
      pill dispensers at home via videoconference, on treatment retention and overdose prevention.&#xD;
      Broad dissemination of this new intervention could help communities across the nation expand&#xD;
      and advance their capacity to increase B/N treatment engagement and retention, enhance&#xD;
      medication adherence, and prevent overdose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate an innovative strategy among opioid use disorder&#xD;
      patients being discharged from detox. This study will evaluate the extent to which remote&#xD;
      motivational enhancement sessions via videoconference and the option for flexible daily&#xD;
      dosing at home with MySafeRx can improve engagement and retention with Buprenorphine/Naloxone&#xD;
      (B/N) treatment after detox in a county where access to B/N treatment has primarily been&#xD;
      provided with in-person, onsite, daily dosing. This study seeks to expand the investigators&#xD;
      understanding about what works to prevent opioid overdose by evaluating the effects of remote&#xD;
      motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox&#xD;
      facility and during early treatment in order to increase treatment engagement with daily&#xD;
      outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to&#xD;
      access the MySafeRx app and complete their daily motivational interview sessions. In&#xD;
      addition, the study seeks to evaluate the effects of using a locked medication dispenser. The&#xD;
      role of the dispenser has not been fully evaluated in the past, and evaluation is needed to&#xD;
      determine if the dispenser is necessary at the start of a treatment program or only in&#xD;
      response to those participants having issues with adherence or participants that are&#xD;
      struggling. This pilot study will generate new knowledge about the most effective way to&#xD;
      prevent overdose and engage patients in B/N treatment with observed daily dosing.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The investigators will examine whether acceptable levels of satisfaction with the MySafeRx&#xD;
      platform, specifically the electronic pill dispenser, are achieved at the end of the pilot&#xD;
      period.&#xD;
&#xD;
      Primary Aim:&#xD;
&#xD;
      Aim 1: To assess the acceptability of the electronic medication dispenser and evaluate the&#xD;
      impact of using an alternative adaptive assessment-based procedure, by comparing MySafeRx&#xD;
      Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and&#xD;
      MySafeRx Group B (participants only receive the electronic medication dispensers based on&#xD;
      clinical evaluation and need after assessment at regular time intervals).&#xD;
&#xD;
      Secondary Aims:&#xD;
&#xD;
      Aim 2: To examine the differences in positive urine toxicology screens between MySafeRx Group&#xD;
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser&#xD;
      based on clinical need)&#xD;
&#xD;
      Aim 3: To examine medication adherence to B/N by assessing the differences between MySafeRx&#xD;
      Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication&#xD;
      dispenser based on clinical need) in the total number of observed B/N doses taken in the&#xD;
      first 28 days, between weeks 3-6.&#xD;
&#xD;
      Aim 4: To examine the differential impact of two tele-health interventions of MySafeRx Group&#xD;
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser&#xD;
      based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing&#xD;
      through 24 weeks.&#xD;
&#xD;
      Exploratory COVID-19 Objectives:&#xD;
&#xD;
      Aim 5: To examine the differences of COVID-19 infection between MySafeRx Group A and MySafeRx&#xD;
      Group B and compare with ACTS overall program incidence rate during the time period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 26, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of Medication Dispenser</measure>
    <time_frame>12 weeks</time_frame>
    <description>To examine the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing. MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals). MySafeRx Participant Satisfaction Survey to assess for acceptability of electronic dispenser.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemically-Confirmed Illicit Opioid Use</measure>
    <time_frame>24 weeks</time_frame>
    <description>To examine the differences in illicit opioid use throughout the 24 weeks of the study as measured by urine toxicology testing every 4 weeks between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need). Positive results for fentanyl, opiates, methadone and oxycodone will be measured at 6 time points every 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient Buprenorphine Medication Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>To examine medication adherence to Buprenorphine (B/N) by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 12 weeks. To be measured by examining adherence data from the study site EHR system and MySafeRx application.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient Buprenorphine Treatment Engagement/ Retention</measure>
    <time_frame>24 weeks</time_frame>
    <description>To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.To be measured by examining adherence data from the study site EHR system.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of days engaged in observed daily dosing of Buprenorphine during first 2 weeks.</measure>
    <time_frame>Between the day after detox discharge to two-week time point</time_frame>
    <description>To examine the difference in engagement defined as the proportion of participants assigned to Group A or Group B, who have an observed B/N dosing on at least 10 out of the first 14 days.</description>
  </other_outcome>
  <other_outcome>
    <measure>COVID-19 Infections</measure>
    <time_frame>24 weeks</time_frame>
    <description>To examine the differences of COVID-19 infection between MySafeRx Group A (coaching + medication dispenser) MySafeRx Group B in comparison with the local treatment sites overall program incidence rate during the time period. Measured with COVID-19 self-report survey.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)</measure>
    <time_frame>24 weeks</time_frame>
    <description>To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on the number of self-reported, county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Opioid-Related Death Rates</measure>
    <time_frame>24 weeks</time_frame>
    <description>To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on all opioid-related deaths (in which opioids were present at time of death), as collected through county coroner reports and community network reports, throughout the 24 weeks of the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>MySafeRx Group A-(coaching + medication dispenser)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MySafeRx Group B-(coaching + dispenser based on clinical need)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a manual lockbox, and a standardized protocol for supervising self-administration of medication via videoconferencing. Participants will be assessed bi-weekly by their clinical team for substance abuse, coaching and medication adherence, compliance with urine drug screen policies, safety/ risk or mental health concerns, and diversion. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MySafeRx Inspire Plus</intervention_name>
    <description>The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.</description>
    <arm_group_label>MySafeRx Group A-(coaching + medication dispenser)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MySafeRx Inspire Flex</intervention_name>
    <description>The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team.</description>
    <arm_group_label>MySafeRx Group B-(coaching + dispenser based on clinical need)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 to 65 years&#xD;
&#xD;
          -  opioid use disorder&#xD;
&#xD;
          -  stepping down from inpatient detox services&#xD;
&#xD;
          -  willing to engage in daily outpatient supervised dosing of B/N.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA &lt; 25/30&#xD;
             relative exclusion requiring PI approval, absolute exclusion for MOCA&lt;21/30)&#xD;
&#xD;
          -  homeless&#xD;
&#xD;
          -  reporting active homicidal or suicidal ideation with an imminent plan&#xD;
&#xD;
          -  current mania or psychosis&#xD;
&#xD;
          -  expected incarceration in next 3 months (those that are incarcerated during the study&#xD;
             will be removed from the study)&#xD;
&#xD;
          -  unable or unwilling to use a mobile device&#xD;
&#xD;
          -  medical contraindication to BUP&#xD;
&#xD;
          -  unable to complete baseline assessments&#xD;
&#xD;
          -  unstable medical illness who expect hospitalization in the next 3 months pregnant&#xD;
             women (if a patient becomes pregnant while participating in this study, they will be&#xD;
             withdrawn)&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  court-ordered individuals&#xD;
&#xD;
          -  unable to speak or read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Moore, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zev Schuman-Olivier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cambridge Health Alliance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ACTS Adult Addiction Receiving Facility (AARF)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.</citation>
    <PMID>30249279</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</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>Yes</sharing_ipd>
    <ipd_description>De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>After publication and within 12 months of completion of the analysis of study primary aims, anonymous and de-identified data will be made available at the Open Science Framework (http://osf.io/) and/or Harvard Dataverse (https://dataverse.harvard.edu/) so that other investigators can verify or follow-up on the reported analyses.</ipd_time_frame>
    <ipd_access_criteria>Anonymous and de-identified data will be stored on the Open Science Framework website (http://osf.io/) and/or Harvard Dataverse to be made available to other researchers to verify the research results. Before publication, only USF and CHA investigators will have direct access to the data, and only the CHA HERLab investigators will have access to the analyses.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04449744/ICF_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/NCT04449744
org study id: PRO00038163 - Pilot
secondary id: R01CE003039
nct id: NCT04449744
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Opioid overdoses are a significant problem nationwide and novel interventions that can
      prevent overdose by improving buprenorphine treatment for opioid use disorder are a public
      health priority. This study will both investigate the effects of starting remote motivational
      enhancement during inpatient detoxification on rates of engagement in Buprenorphine/ Naloxone
      (B/N) treatment and evaluate the impact of MySafeRx, a mobile device application which
      integrates remote motivational coaching with daily observed dosing from secure electronic
      pill dispensers at home via videoconference, on treatment retention and overdose prevention.
      Broad dissemination of this new intervention could help communities across the nation expand
      and advance their capacity to increase B/N treatment engagement and retention, enhance
      medication adherence, and prevent overdose.
The objective of this study is to evaluate an innovative strategy among opioid use disorder
      patients being discharged from detox. This study will evaluate the extent to which remote
      motivational enhancement sessions via videoconference and the option for flexible daily
      dosing at home with MySafeRx can improve engagement and retention with Buprenorphine/Naloxone
      (B/N) treatment after detox in a county where access to B/N treatment has primarily been
      provided with in-person, onsite, daily dosing. This study seeks to expand the investigators
      understanding about what works to prevent opioid overdose by evaluating the effects of remote
      motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox
      facility and during early treatment in order to increase treatment engagement with daily
      outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to
      access the MySafeRx app and complete their daily motivational interview sessions. In
      addition, the study seeks to evaluate the effects of using a locked medication dispenser. The
      role of the dispenser has not been fully evaluated in the past, and evaluation is needed to
      determine if the dispenser is necessary at the start of a treatment program or only in
      response to those participants having issues with adherence or participants that are
      struggling. This pilot study will generate new knowledge about the most effective way to
      prevent overdose and engage patients in B/N treatment with observed daily dosing.

      Hypothesis:

      The investigators will examine whether acceptable levels of satisfaction with the MySafeRx
      platform, specifically the electronic pill dispenser, are achieved at the end of the pilot
      period.

      Primary Aim:

      Aim 1: To assess the acceptability of the electronic medication dispenser and evaluate the
      impact of using an alternative adaptive assessment-based procedure, by comparing MySafeRx
      Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and
      MySafeRx Group B (participants only receive the electronic medication dispensers based on
      clinical evaluation and need after assessment at regular time intervals).

      Secondary Aims:

      Aim 2: To examine the differences in positive urine toxicology screens between MySafeRx Group
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser
      based on clinical need)

      Aim 3: To examine medication adherence to B/N by assessing the differences between MySafeRx
      Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication
      dispenser based on clinical need) in the total number of observed B/N doses taken in the
      first 28 days, between weeks 3-6.

      Aim 4: To examine the differential impact of two tele-health interventions of MySafeRx Group
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser
      based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing
      through 24 weeks.

      Exploratory COVID-19 Objectives:

      Aim 5: To examine the differences of COVID-19 infection between MySafeRx Group A and MySafeRx
      Group B and compare with ACTS overall program incidence rate during the time period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability of Medication Dispenser
time frame: 12 weeks
description: To examine the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing. MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals). MySafeRx Participant Satisfaction Survey to assess for acceptability of electronic dispenser.
measure: Biochemically-Confirmed Illicit Opioid Use
time frame: 24 weeks
description: To examine the differences in illicit opioid use throughout the 24 weeks of the study as measured by urine toxicology testing every 4 weeks between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need). Positive results for fentanyl, opiates, methadone and oxycodone will be measured at 6 time points every 4 weeks.
measure: Outpatient Buprenorphine Medication Adherence
time frame: 12 weeks
description: To examine medication adherence to Buprenorphine (B/N) by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 12 weeks. To be measured by examining adherence data from the study site EHR system and MySafeRx application.
measure: Outpatient Buprenorphine Treatment Engagement/ Retention
time frame: 24 weeks
description: To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.To be measured by examining adherence data from the study site EHR system.
measure: Proportion of days engaged in observed daily dosing of Buprenorphine during first 2 weeks.
time frame: Between the day after detox discharge to two-week time point
description: To examine the difference in engagement defined as the proportion of participants assigned to Group A or Group B, who have an observed B/N dosing on at least 10 out of the first 14 days.
measure: COVID-19 Infections
time frame: 24 weeks
description: To examine the differences of COVID-19 infection between MySafeRx Group A (coaching + medication dispenser) MySafeRx Group B in comparison with the local treatment sites overall program incidence rate during the time period. Measured with COVID-19 self-report survey.
measure: Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)
time frame: 24 weeks
description: To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on the number of self-reported, county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study.
measure: Opioid-Related Death Rates
time frame: 24 weeks
description: To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on all opioid-related deaths (in which opioids were present at time of death), as collected through county coroner reports and community network reports, throughout the 24 weeks of the study.
arm group label: MySafeRx Group A-(coaching + medication dispenser)
arm group type: Active Comparator
description: The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
arm group label: MySafeRx Group B-(coaching + dispenser based on clinical need)
arm group type: Experimental
description: The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a manual lockbox, and a standardized protocol for supervising self-administration of medication via videoconferencing. Participants will be assessed bi-weekly by their clinical team for substance abuse, coaching and medication adherence, compliance with urine drug screen policies, safety/ risk or mental health concerns, and diversion. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study.
intervention type: Other
intervention name: MySafeRx Inspire Plus
description: The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
arm group label: MySafeRx Group A-(coaching + medication dispenser)
intervention type: Other
intervention name: MySafeRx Inspire Flex
description: The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team.
arm group label: MySafeRx Group B-(coaching + dispenser based on clinical need)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Moore, PhD
role: Principal Investigator
affiliation: University of South Florida
last name: Zev Schuman-Olivier, MD
role: Principal Investigator
affiliation: Cambridge Health Alliance
facility: 
country: United States
citation: Schuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.
PMID: 30249279
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: Yes
ipd description: De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: After publication and within 12 months of completion of the analysis of study primary aims, anonymous and de-identified data will be made available at the Open Science Framework (http://osf.io/) and/or Harvard Dataverse (https://dataverse.harvard.edu/) so that other investigators can verify or follow-up on the reported analyses.
ipd access criteria: Anonymous and de-identified data will be stored on the Open Science Framework website (http://osf.io/) and/or Harvard Dataverse to be made available to other researchers to verify the research results. Before publication, only USF and CHA investigators will have direct access to the data, and only the CHA HERLab investigators will have access to the analyses.
provided document: 