<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/NCT03766893</url>
  </required_header>
  <id_info>
    <org_study_id>1112133</org_study_id>
    <nct_id>NCT03766893</nct_id>
  </id_info>
  <brief_title>Medication Maintenance Therapy in Community Pharmacy Settings</brief_title>
  <acronym>MATPharm</acronym>
  <official_title>Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lifespan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rhode Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lifespan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to examine how the pharmacy can better optimize treatment expansion&#xD;
      by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a&#xD;
      collaborative pharmacy practice agreement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be the first to develop and use a collaborative pharmacy practice agreement&#xD;
      (CPA) for medication assisted treatment (MAT) intended for statewide application. This will&#xD;
      also be the first study to use a randomized controlled trial design to test the multisite&#xD;
      implementation of known effective interventions to treat opioid use disorder and prevent&#xD;
      fatal opioid overdose (treatment with buprenorphine and natlrexone) in a pharmacy setting.&#xD;
      Understanding how this model can improve engagement in care within innovative systems of MAT&#xD;
      delivery like the Rhode Island Centers of Excellence in MAT model as well as the more&#xD;
      traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and&#xD;
      longer time on stabilized MAT doses advances the science of addiction health services.&#xD;
&#xD;
      This study presents an opportunity to compare clinical outcomes of patients randomized to&#xD;
      receive the same medications but in different settings that are equipped with differing&#xD;
      levels of counseling expectations and access to wrap-around services. In this way, the trial&#xD;
      helps to inform whether-and for whom--the limited support services in the pharmacy are&#xD;
      sufficient to engage and retain patients in MAT, or if ready access to comprehensive services&#xD;
      are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making&#xD;
      pharmacists the most accessible health care professionals. This model could redefine the role&#xD;
      of the pharmacy.&#xD;
&#xD;
      The initial phase of the study (Phase 1) involves preparation for and conduct of a pilot&#xD;
      study of the pharmacy MAT care model.&#xD;
&#xD;
      The aims of the first study phase (R21 grant) are:&#xD;
&#xD;
        -  Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using&#xD;
           buprenorphine and naltrexone.&#xD;
&#xD;
        -  Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections,&#xD;
           assess the feasibility and timing of randomization and transfer to a CPA pharmacy&#xD;
           providing MAT post-release. This targeted assessment will inform the R33 design.&#xD;
&#xD;
        -  Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility&#xD;
           of medication dispensing, administration, and monitoring in the pharmacy, and&#xD;
           determining patient acceptability of this model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacists' dispensing of MAT medications</measure>
    <time_frame>up to one month</time_frame>
    <description>Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacists' monitoring of MAT care</measure>
    <time_frame>up to one month</time_frame>
    <description>Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale</measure>
    <time_frame>up to one month</time_frame>
    <description>7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy?&#xD;
With responses ranging from 1 to 7 as:&#xD;
totally unacceptable&#xD;
unacceptable&#xD;
slightly unacceptable&#xD;
neutral&#xD;
slightly acceptable&#xD;
acceptable&#xD;
perfectly acceptable&#xD;
Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient acceptability of pharmacy-provided MAT care: Likert scale</measure>
    <time_frame>up to one month</time_frame>
    <description>7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as:&#xD;
totally unacceptable&#xD;
unacceptable&#xD;
slightly unacceptable&#xD;
neutral&#xD;
slightly acceptable&#xD;
acceptable&#xD;
perfectly acceptable&#xD;
Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>Pharmacy based opioid use disorder care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine / Naloxone Oral Product</intervention_name>
    <description>To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.</description>
    <arm_group_label>Pharmacy based opioid use disorder care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>injectable naltrexone</intervention_name>
    <description>To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.</description>
    <arm_group_label>Pharmacy based opioid use disorder care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacy maintenance addiction care</intervention_name>
    <description>Patients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).</description>
    <arm_group_label>Pharmacy based opioid use disorder care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  English speaking; currently enrolled at a CODAC site in Rhode Island for the treatment&#xD;
             of opioid use disorder;&#xD;
&#xD;
          -  maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2&#xD;
             days;&#xD;
&#xD;
          -  no stable co-morbid illnesses likely to progress clinically during the pilot study;&#xD;
&#xD;
          -  able and willing to provide written informed consent and locator information (working&#xD;
             telephone and &gt;2 contacts) to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently pregnant or trying to get pregnant;&#xD;
&#xD;
          -  plans to move or leave the state during the study, including pending legal action;&#xD;
&#xD;
          -  self reported past year suicide attempt or self-reported past year suicidal thoughts&#xD;
             with a plan;&#xD;
&#xD;
          -  any condition that, in the researchers' judgment, interferes with safe study&#xD;
             participation or adherence to study procedures, including but not limited to a mental,&#xD;
             medical or other substance use disorder that is likely to require ongoing, intense&#xD;
             clinical management during the pilot study.&#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>Traci C Green</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lifespan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lifespan</investigator_affiliation>
    <investigator_full_name>Traci Green</investigator_full_name>
    <investigator_title>Senior Research Scientist, Associate Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03766893
org study id: 1112133
nct id: NCT03766893
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this study is to examine how the pharmacy can better optimize treatment expansion
      by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a
      collaborative pharmacy practice agreement.
This study will be the first to develop and use a collaborative pharmacy practice agreement
      (CPA) for medication assisted treatment (MAT) intended for statewide application. This will
      also be the first study to use a randomized controlled trial design to test the multisite
      implementation of known effective interventions to treat opioid use disorder and prevent
      fatal opioid overdose (treatment with buprenorphine and natlrexone) in a pharmacy setting.
      Understanding how this model can improve engagement in care within innovative systems of MAT
      delivery like the Rhode Island Centers of Excellence in MAT model as well as the more
      traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and
      longer time on stabilized MAT doses advances the science of addiction health services.

      This study presents an opportunity to compare clinical outcomes of patients randomized to
      receive the same medications but in different settings that are equipped with differing
      levels of counseling expectations and access to wrap-around services. In this way, the trial
      helps to inform whether-and for whom--the limited support services in the pharmacy are
      sufficient to engage and retain patients in MAT, or if ready access to comprehensive services
      are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making
      pharmacists the most accessible health care professionals. This model could redefine the role
      of the pharmacy.

      The initial phase of the study (Phase 1) involves preparation for and conduct of a pilot
      study of the pharmacy MAT care model.

      The aims of the first study phase (R21 grant) are:

        -  Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using
           buprenorphine and naltrexone.

        -  Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections,
           assess the feasibility and timing of randomization and transfer to a CPA pharmacy
           providing MAT post-release. This targeted assessment will inform the R33 design.

        -  Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility
           of medication dispensing, administration, and monitoring in the pharmacy, and
           determining patient acceptability of this model.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacists' dispensing of MAT medications
time frame: up to one month
description: Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.
measure: Pharmacists' monitoring of MAT care
time frame: up to one month
description: Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.
measure: Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale
time frame: up to one month
description: 7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy?
With responses ranging from 1 to 7 as:
totally unacceptable
unacceptable
slightly unacceptable
neutral
slightly acceptable
acceptable
perfectly acceptable
Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.
measure: Patient acceptability of pharmacy-provided MAT care: Likert scale
time frame: up to one month
description: 7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as:
totally unacceptable
unacceptable
slightly unacceptable
neutral
slightly acceptable
acceptable
perfectly acceptable
Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.
arm group label: Pharmacy based opioid use disorder care
arm group type: Experimental
description: A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.
intervention type: Drug
intervention name: Buprenorphine / Naloxone Oral Product
description: To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.
arm group label: Pharmacy based opioid use disorder care
intervention type: Drug
intervention name: injectable naltrexone
description: To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.
arm group label: Pharmacy based opioid use disorder care
intervention type: Other
intervention name: Pharmacy maintenance addiction care
description: Patients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).
arm group label: Pharmacy based opioid use disorder care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Traci C Green
role: Principal Investigator
affiliation: Lifespan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lifespan
investigator full name: Traci Green
investigator title: Senior Research Scientist, Associate Professor of Emergency Medicine
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
mesh term: Buprenorphine
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: Naloxone