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: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)

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. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.

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)
• 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

Adverse event data was collected from the entire duration for which each patient was enrolled in the study (minimum of 3 days).

The definitions of adverse event and serious adverse event do not differ from the definitions provided by clinicaltrials.gov.

Adverse event data was collected by inpatient-care nursing staff members who continuously monitored each patient throughout their time enrolled in the study.

1. This is a single-arm study with only an intervention arm and no control. As a result, it is not possible to draw any causal conclusions. Follow-up studies are needed to further validate the preliminary signals and patterns observed in this study.
2. There were three patients who experienced a dose change in marijuana from 40mg to 80mg CBD.
3. Some outcome measurements were missing due to the inability of patients to respond to questions.