Chronic Pain, Opioid Use
Conditions
Keywords
Chronic pain, Opioid medication, Medical Marijuana
Brief summary
Medical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients, cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, prior to receiving medical cannabis. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
Detailed description
Opioid use for pain has increased drastically over last decade with disastrous results that lead to an epidemic of overdoses and deaths in the United States. Philadelphia has been described as "ground zero" in the opiate epidemic of overdoses and deaths in the United States. Some initial clinical experience shows that medical marijuana can potentially assist patients suffering from certain serious medical conditions by alleviating pain and improving quality of life, allowing them to discontinue opiates. Medical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. The medical marijuana law in Pennsylvania was passed in 2016 with the hope that this might alleviate the opiate crisis. The opioid death rate in Pennsylvania was 37.9 per 100,000 people. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. This can create a disparity in care of chronic pain patients. Methods: Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, which measures sensory, affective and evaluative dimensions of pain prior to receiving medical cannabis and then at 5 months. Each patient will be evaluated by a physician who is certified to evaluate patients for Medical Cannabis. If the patient qualifies for Medical Cannabis the next step is for the patient to register on the state of Pennsylvania medical marijuana website. Medical conditions that qualify patient in the states of Pennsylvania for medical marijuana are Amyotrophic lateral sclerosis, Cancer, Crohn's disease, multiple sclerosis, Neurodegenerative diseases, neuropathies, chronic or intractable pain of neuropathic origin. After the patient registers the physician will also certify them on the website. After the patients are certified they will apply for medical marijuana card. Once the patient receives a medical marijuana card the patient will start an opioid weaning plan. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary and will be able to choose their medical cannabis product. The Curaleaf medical cannabis dispensary will have a list of patients and participants will be able to choose from the cannabis products. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
Interventions
OTHERWe will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.
We will monitor patient response to medical marijuana as opioid alternative. This will be given to patient who otherwise could not get intervention secondary to cost. We want to show that medical marijuana is a safer alternative to opioids in this population of patients
Sponsors
University of Pennsylvania
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who are on chronic opioids medication for pain and have failed to wean off in past. * These patients also have diagnoses that makes them eligible for medical marijuana and are willing to try it as an alternative to opioids and cost prohibited from trialing in the past
Exclusion criteria
* History of Schizophrenia * Acute psychiatric disorder * Licensed to carry firearm * Federal job that excludes them from receiving medical marijuana.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Numeric Rating Scale at 5 Months From Baseline | From enrollment monthly until the end of treatment at 5 months | The Numeric Rating Scale is measured from Zero which is equivalent to no pain to 10 which indicates the worst possible pain. |
| Change From Baseline to 5 Months in Daily Opioid Use (Morphine Milligram Equivalents) | From Baseline to 5 months | Total daily opioid dose was converted to Morphine Milligram Equivalents (MME) using standard opioid conversion tables. The value reported represents the mean change in daily MME from baseline to 5 months. Negative values indicate a reduction in opioid use. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFranklin E Caldera, DO,MBA
Univeristy of Pennsylvania
Participant flow
Recruitment details
Patient were recruited from outpatient chronic pain clinic from 9/1/2024 to 10/1/2025
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 11.06 |
| Baseline opioid dose in Morphine milli-equivalents | 46.88 mg/day morphine equivalents STANDARD_DEVIATION 29 |
| Baseline pain intensity using Numeric Pain Rating Scale | 7 units on a 0-10 scale STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 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 | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Rand Short Form 36 Questionaire Health Change score | 38.8 Scores on a 0-100 scale |
| Rand Short Form 36 Questionaire Physical Functioning score | 15.34 Scores on a 0-100 scale |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
None listed