Pain
Conditions
Keywords
pain management, terminally ill
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.
Interventions
oral capsule, high ratio CBD:THC
Sponsors
The Connecticut Hospice Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
Participants were excluded from participating if they were unable to take orally administered medications.
Participants by arm
| Arm | Count |
|---|---|
| Single Treatment Arm Marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
Medical Marijuana: oral capsule, high ratio CBD:THC | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Less Than 3 Days of Data | 6 |
Baseline characteristics
| Characteristic | Single Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 66 years |
| Diagnosis Category Cancer | 55 Participants |
| Diagnosis Category Non-Cancer | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 66 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 66 / 66 |
| other Total, other adverse events | 1 / 66 |
| serious Total, serious adverse events | 1 / 66 |
Outcome results
Primary
Primary Reduction of Pain
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.
Time frame: minumum 3 days
Population: Patients in hospice care on regular scheduled opioid administration for pain management.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | Primary Reduction of Pain | Pain level at baseline | 2.55 units on a scale from 0 to 10 | Standard Deviation 2.46 |
| Single Treatment Arm | 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
Reduction in Overall Opioid Utilization
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.
Time frame: minimum of 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | Reduction in Overall Opioid Utilization | Opiates administered at Baseline | 309.84 medical morphine equivalents (mg) | Standard Deviation 775.62 |
| Single Treatment Arm | Reduction in Overall Opioid Utilization | Opiates administered at the end of study | 285.54 medical morphine equivalents (mg) | Standard Deviation 430.76 |
Secondary
Improved Oxygen Saturation
Oxygen saturation was reported as a percentage, the greater the % O2 saturation the more positive the outcome.
Time frame: minimum 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | Improved Oxygen Saturation | O2 Saturation at Baseline | 94.86 percent | Standard Deviation 2.53 |
| Single Treatment Arm | Improved Oxygen Saturation | O2 Saturation at the end of study | 94.10 percent | Standard Deviation 2.55 |
Secondary
Improvement in Overall Patient Well Being
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.
Time frame: minimum 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm | 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
Reduction or Prevention of Nausea and Vomiting
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).
Time frame: minimum 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | Reduction or Prevention of Nausea and Vomiting | Nausea at Baseline | 0.46 units on a scale from 0 to 10 | Standard Deviation 1.33 |
| Single Treatment Arm | 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 |
Secondary
Weight Stabilization With Increased Appetite
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.
Time frame: minimum 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Treatment Arm | 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 |
| Single Treatment Arm | Weight Stabilization With Increased Appetite | Appetite at Baseline | 1.93 units on a scale from 1 to 4 | Standard Deviation 1.01 |