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Marijuana in Combination With Opioids in Palliative and Hospice Patients

Sponsor
The Connecticut Hospice Inc. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03233633
Collaborator
(none)
66
Enrollment
1
Location
1
Arm
67.7
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Medical Marijuana
 Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
Actual Study Start Date :
May 10, 2017
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Single treatment arm

marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting

Drug: Medical Marijuana
oral capsule, high ratio CBD:THC
Other Names:
  • cannabidiol
  • medical cannabis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. primary reduction of pain and reduction in overall opioid utilization [minumum 5 days]

      numeric pain scale

    Secondary Outcome Measures

    1. improvement in overall patient well being [minimum 5 days]

      modified Edmonton Assessment Scale

    2. weight stabilization with increased appetite [minimum 5 days]

      modified Edmonton Assessment Scale

    3. improved oxygen saturation [minimum 5 days]

      modified Edmonton Assessment Scale

    4. improvement or prevention of nausea and vomiting [minimum 5 days]

      modified Edmonton Assessment Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18

    • Alert adults

    • requiring opioids for pain management (routine or as needed)

    • cancer diagnosis or non-cancer diagnosis as their terminal illness

    Exclusion Criteria:

    • pregnant women

    • Age < 18

    • minimally or unresponsive patients unable to take oral medications

    • agitated combative patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Connecticut Hospice Inc. Branford Connecticut United States 06405

    Sponsors and Collaborators

    • The Connecticut Hospice Inc.

    Investigators

    • Principal Investigator: Theodore Zanker, MD, The Connecticut Hospice Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Theodore Zanker MD, Principal Investigator, The Connecticut Hospice Inc.
    ClinicalTrials.gov Identifier:
    NCT03233633
    Other Study ID Numbers:
    • WIRB Protocol 20161880-1167645
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Theodore Zanker MD, Principal Investigator, The Connecticut Hospice Inc.
    pain management
    terminally ill
    Additional relevant MeSH terms:
    Marijuana Abuse
    Cannabidiol

    Study Results

    No Results Posted as of Mar 16, 2022