Marijuana in Combination With Opioids in Palliative and Hospice Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients

Conditions
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Pain

Intervention / Treatment
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* Drug: Medical Marijuana


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single treatment arm<br>marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting | Drug: Medical Marijuana<br>* oral capsule, high ratio CBD:THC<br>* Other names: medical cannabis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary reduction of pain and reduction in overall opioid utilization | numeric pain scale | minumum 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in overall patient well being | modified Edmonton Assessment Scale | minimum 5 days | 
| weight stabilization with increased appetite | modified Edmonton Assessment Scale | minimum 5 days | 
| improved oxygen saturation | modified Edmonton Assessment Scale | minimum 5 days | 
| improvement or prevention of nausea and vomiting | modified Edmonton Assessment Scale | minimum 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, terminally ill