Marijuana in Combination With Opioids in Palliative and Hospice Patients
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/29/2017 |
| Start Date: | May 10, 2017 |
| End Date: | November 2017 |
Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
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.
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.
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.
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
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