<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/NCT03233633</url>
  </required_header>
  <id_info>
    <org_study_id>WIRB Protocol 20161880-1167645</org_study_id>
    <nct_id>NCT03233633</nct_id>
  </id_info>
  <brief_title>Marijuana in Combination With Opioids in Palliative and Hospice Patients</brief_title>
  <official_title>Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Connecticut Hospice Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Connecticut Hospice Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Objectives: Primary reduction of pain and reduction in overall opioid utilization.&#xD;
      Secondary improvement in overall patient well being, weight stabilization with increased&#xD;
      appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.&#xD;
&#xD;
      Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain&#xD;
      and symptom management.&#xD;
&#xD;
      Study Population: This study specifically will enroll cancer and non-cancer patients as a&#xD;
      primary diagnosis suffering from pain and having a terminal illness (defined as having less&#xD;
      than 6 months to live) requiring end of life care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Endpoint: Death or discharge&#xD;
&#xD;
      Secondary and Exploratory endpoints:Secondary improvement in overall patient well being,&#xD;
      weight stabilization with increased appetite, improved oxygen saturation, improvement or&#xD;
      prevention of nausea and vomiting.&#xD;
&#xD;
      Study design: This will be an open-label study. Patients will choose to participate in a&#xD;
      Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid&#xD;
      therapy.&#xD;
&#xD;
      Subject number: Minimum 66 patients&#xD;
&#xD;
      Treatment Duration: Minimum 5 days&#xD;
&#xD;
      Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score&#xD;
      will be recorded. For the duration of the study (at least five days) changes in opioid doses&#xD;
      and numeric pain scores will be tracked daily.&#xD;
&#xD;
      Marijuana will be administered to the patient via oral route three times daily for at least&#xD;
      five days. Patients will receive standardized CBD:THC product provided by NIDA.&#xD;
&#xD;
      On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline&#xD;
      appetite, depression, nausea, vomiting, overall well-being, and anxiety.&#xD;
&#xD;
      Data Tracking: Primary objective tracking will include average numeric pain scores and number&#xD;
      of opioid dosage increases and average daily opioid amount (mg equivalents of morphine).&#xD;
      Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points&#xD;
      from the modified Edmonton Assessment Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">August 5, 2022</completion_date>
  <primary_completion_date type="Actual">August 5, 2022</primary_completion_date>
  <phase>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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>primary reduction of pain and reduction in overall opioid utilization</measure>
    <time_frame>minumum 5 days</time_frame>
    <description>numeric pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement in overall patient well being</measure>
    <time_frame>minimum 5 days</time_frame>
    <description>modified Edmonton Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight stabilization with increased appetite</measure>
    <time_frame>minimum 5 days</time_frame>
    <description>modified Edmonton Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improved oxygen saturation</measure>
    <time_frame>minimum 5 days</time_frame>
    <description>modified Edmonton Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvement or prevention of nausea and vomiting</measure>
    <time_frame>minimum 5 days</time_frame>
    <description>modified Edmonton Assessment Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Single treatment arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Marijuana</intervention_name>
    <description>oral capsule, high ratio CBD:THC</description>
    <arm_group_label>Single treatment arm</arm_group_label>
    <other_name>cannabidiol</other_name>
    <other_name>medical cannabis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Alert adults&#xD;
&#xD;
          -  requiring opioids for pain management (routine or as needed)&#xD;
&#xD;
          -  cancer diagnosis or non-cancer diagnosis as their terminal illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  minimally or unresponsive patients unable to take oral medications&#xD;
&#xD;
          -  agitated combative patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodore Zanker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Connecticut Hospice Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Connecticut Hospice Inc.</name>
      <address>
        <city>Branford</city>
        <state>Connecticut</state>
        <zip>06405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Connecticut Hospice Inc.</investigator_affiliation>
    <investigator_full_name>Theodore Zanker MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pain management</keyword>
  <keyword>terminally ill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>October 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03233633/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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>October 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03233633/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 23, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03233633
org study id: WIRB Protocol 20161880-1167645
nct id: NCT03233633
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Study Objectives: Primary reduction of pain and reduction in overall opioid utilization.
      Secondary improvement in overall patient well being, weight stabilization with increased
      appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

      Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain
      and symptom management.

      Study Population: This study specifically will enroll cancer and non-cancer patients as a
      primary diagnosis suffering from pain and having a terminal illness (defined as having less
      than 6 months to live) requiring end of life care.
Primary Endpoint: Death or discharge

      Secondary and Exploratory endpoints:Secondary improvement in overall patient well being,
      weight stabilization with increased appetite, improved oxygen saturation, improvement or
      prevention of nausea and vomiting.

      Study design: This will be an open-label study. Patients will choose to participate in a
      Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid
      therapy.

      Subject number: Minimum 66 patients

      Treatment Duration: Minimum 5 days

      Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score
      will be recorded. For the duration of the study (at least five days) changes in opioid doses
      and numeric pain scores will be tracked daily.

      Marijuana will be administered to the patient via oral route three times daily for at least
      five days. Patients will receive standardized CBD:THC product provided by NIDA.

      On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline
      appetite, depression, nausea, vomiting, overall well-being, and anxiety.

      Data Tracking: Primary objective tracking will include average numeric pain scores and number
      of opioid dosage increases and average daily opioid amount (mg equivalents of morphine).
      Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points
      from the modified Edmonton Assessment Scale.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: primary reduction of pain and reduction in overall opioid utilization
time frame: minumum 5 days
description: numeric pain scale
measure: improvement in overall patient well being
time frame: minimum 5 days
description: modified Edmonton Assessment Scale
measure: weight stabilization with increased appetite
time frame: minimum 5 days
description: modified Edmonton Assessment Scale
measure: improved oxygen saturation
time frame: minimum 5 days
description: modified Edmonton Assessment Scale
measure: improvement or prevention of nausea and vomiting
time frame: minimum 5 days
description: modified Edmonton Assessment Scale
arm group label: Single treatment arm
arm group type: Other
description: marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
intervention type: Drug
intervention name: Medical Marijuana
description: oral capsule, high ratio CBD:THC
arm group label: Single treatment arm
other name: cannabidiol
other name: medical cannabis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theodore Zanker, MD
role: Principal Investigator
affiliation: The Connecticut Hospice Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Connecticut Hospice Inc.
investigator full name: Theodore Zanker MD
investigator title: Principal Investigator
mesh term: Marijuana Abuse
mesh term: Cannabidiol
sharing ipd: No
provided document: 
provided document: 
submitted: June 23, 2023