Trial Outcomes & Findings for Marijuana in Combination With Opioids in Palliative and Hospice Patients (NCT NCT03233633)

NCT ID: NCT03233633

Last Updated: 2024-11-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 66 participants
• Primary outcome timeframe: minumum 3 days
• Results posted on: 2024-11-06

Participant Flow

Enrollment of Terminal Patients with pain and receiving routine opioid therapy within an inpatient Hospice Hospital setting commencing 05/10/2017 and ending 8/5/2022

Participants were excluded from participating if they were unable to take orally administered medications.

Participant milestones

Measure	Single Treatment Arm Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Overall Study STARTED	66
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Single Treatment Arm Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Overall Study Adverse Event	2
Overall Study Less Than 3 Days of Data	6

Baseline Characteristics

Marijuana in Combination With Opioids in Palliative and Hospice Patients

Baseline characteristics by cohort

Measure	Single Treatment Arm n=66 Participants Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	66 Participants n=5 Participants
Diagnosis Category Cancer	55 Participants n=5 Participants
Diagnosis Category Non-Cancer	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: minumum 3 days

Population: Patients in hospice care on regular scheduled opioid administration for pain management.

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.

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Primary Reduction of Pain Pain level at baseline	2.55 units on a scale from 0 to 10 Standard Deviation 2.46
Primary Reduction of Pain Pain level on the last day of study	1.40 units on a scale from 0 to 10 Standard Deviation 2.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Reduction in Overall Opioid Utilization Opiates administered at Baseline	309.84 medical morphine equivalents (mg) Standard Deviation 775.62
Reduction in Overall Opioid Utilization Opiates administered at the end of study	285.54 medical morphine equivalents (mg) Standard Deviation 430.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Improvement in Overall Patient Well Being Overall well-being at Baseline	3.31 score on a scale from 1 to 10 Standard Deviation 2.64
Improvement in Overall Patient Well Being Overall well-being at the end of study	2.42 score on a scale from 1 to 10 Standard Deviation 2.73

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Weight Stabilization With Increased Appetite Appetite at Baseline	1.93 units on a scale from 1 to 4 Standard Deviation 1.01
Weight Stabilization With Increased Appetite Appetite at the end of study	1.70 units on a scale from 1 to 4 Standard Deviation 1.07

SECONDARY outcome

Timeframe: minimum 3 days

Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Improved Oxygen Saturation O2 Saturation at Baseline	94.86 percent Standard Deviation 2.53
Improved Oxygen Saturation O2 Saturation at the end of study	94.10 percent Standard Deviation 2.55

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Single Treatment Arm n=66 Participants marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting Medical Marijuana: oral capsule, high ratio CBD:THC
Reduction or Prevention of Nausea and Vomiting Nausea at Baseline	0.46 units on a scale from 0 to 10 Standard Deviation 1.33
Reduction or Prevention of Nausea and Vomiting Nausea at the end of study	0.17 units on a scale from 0 to 10 Standard Deviation 0.74

Adverse Events

Medical Marijuana Treatment Arm

Serious events: 1 serious events

Other events: 1 other events

Deaths: 66 deaths

Serious adverse events

Measure

Medical Marijuana Treatment Arm n=66 participants at risk Because this is a single-arm study, all 66 patients included in the study were in the treatment arm, and were administered medical marijuana. All 66 patients were in hospice care and were followed up until either 1) death or 2) unable to take the medication by mouth anymore. Therefore, the study was expected to have 100% all-cause mortality.

Psychiatric disorders Panic Attack

1.5% 1/66 • 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.

Other adverse events

Measure

Medical Marijuana Treatment Arm n=66 participants at risk Because this is a single-arm study, all 66 patients included in the study were in the treatment arm, and were administered medical marijuana. All 66 patients were in hospice care and were followed up until either 1) death or 2) unable to take the medication by mouth anymore. Therefore, the study was expected to have 100% all-cause mortality.

General disorders Dizziness

1.5% 1/66 • 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.

Additional Information

Jim Prota, Director of Pharmacy

Connecticut Hospice

Phone: 203-848-0660

Email: jprota@hospice.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place