Marijuana in Combination With Opioids in Palliative and Hospice Patients

Phase 1

Completed

Conditions: Pain

Interventions: Drug: Medical Marijuana

Registration Number: NCT03233633

Lead Sponsor: The Connecticut Hospice Inc.

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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 66

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single treatment arm	Medical Marijuana	marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting

Primary Outcome Measures

Name	Time	Method
Primary Reduction of Pain	minumum 3 days	A numeric pain scale (Units on a scale with the higher number indicating worse pain) was used to assess pain from a range of 0 to 10.
Reduction in Overall Opioid Utilization	minimum of 3 days	Reduction in overall opioid utilization was measured in units of mg after converting every patient's opioids into equivalent doses (e.g. 2mg of oral dilaudid = 1/4 oral morphine), with a stabilization or reduction in Morphine Mg Equivalents indicating a positive result.

Secondary Outcome Measures

Name	Time	Method
Improvement in Overall Patient Well Being	minimum 3 days	A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. A scale of 1 to 10 was used, where, 1 corresponds to the best well-being and 10 corresponds to the worst well-being.
Weight Stabilization With Increased Appetite	minimum 3 days	A modified Edmonton Assessment Scale was used. The Edmonton Symptom Assessment System (ESAS) is a questionnaire used to rate the intensity of common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. Appetite was analyzed as an ordinal variable where 1 = finished 0\~25% of meal, 2 = 25\~50% of meal, 3 = 50\~75% of meal, 4 = 75\~100% of meal.
Improved Oxygen Saturation	minimum 3 days	Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.
Reduction or Prevention of Nausea and Vomiting	minimum 3 days	A modified Edmonton Assessment Scale was used; the scale is a numeric 0-10 scale (Units on a scale where the higher the number the more nausea and vomiting the patient experienced).