Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic opioid pain patients were cost was barrier to trying medical marijuana | Chronic opioid patient who were unable to wean off opioid in the past and unable to try medical marijuana secondary to cost. Patient who are eligible will be certified for their medical marijuana card and will go to dispensary to get their medical marijuana. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain. | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Numeric Rating Scale at 5 Months From Baseline | The Numeric Rating Scale is measured from Zero which is equivalent to no pain to 10 which indicates the worst possible pain. | From enrollment monthly until the end of treatment at 5 months |
| Change From Baseline to 5 Months in Daily Opioid Use (Morphine Milligram Equivalents) | 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. | From Baseline to 5 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Chronic pain patient on long term opioids who failed to wean off in the past. Patients have no contraindication to medical cannabis and qualify to try as an alternative to opioids.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franklin E Caldera, DO,MBA | Univeristy of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19146 | United States |
We only use non identifiable data and do not plan to use any identifiable individual data.
Not provided
Not provided
Not provided
Not provided
Not provided
Patient were recruited from outpatient chronic pain clinic from 9/1/2024 to 10/1/2025
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Opioid Pain Patients Were Cost Was Barrier to Trying Medical Marijuana | Chronic opioid patient who were unable to wean off opioid in the past and unable to try medical marijuana secondary to cost. Patient who are eligible will be certified for their medical marijuana card and will go to dispensary to get their medical marijuana. We 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Opioid Pain Patients Were Cost Was Barrier to Trying Medical Marijuana | Chronic opioid patients who were unable to wean off opioid in the past and unable to try medical cannabis secondary to cost. Patient who are eligible will be certified for their medical cannabis card and will go to dispensary to get their medical cannabis. We will monitor patient's response to medical cannabis as alternative to opioid for chronic pain. We will monitor patient response to medical cannabis as opioid alternative. This will be given to patient who otherwise could not get intervention secondary to cost. We want to show that medical cannabis is a safer alternative to opioids in this population of patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Numeric Rating Scale at 5 Months From Baseline | The Numeric Rating Scale is measured from Zero which is equivalent to no pain to 10 which indicates the worst possible pain. | Posted | Mean | 95% Confidence Interval | Units on a 0-10 scale | From enrollment monthly until the end of treatment at 5 months |
|
5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Opioid Pain Patients Were Cost Was Barrier to Trying Medical Cannabis | Chronic opioid patient who were unable to wean off opioid in the past and unable to try medical cannabis secondary to cost. Patient who are eligible will be certified for their medical cannabis card and will go to dispensary to get their medical cannabis. We will monitor patient's response to medical cannabis as alternative to opioid for chronic pain.: We will monitor patient response to medical cannabis as opioid alternative. This will be given to patient who otherwise could not get intervention secondary to cost. We want to show that medical cannabis is a safer alternative to opioids in this population of patients |
Not provided
Not provided
Our study had some limitations. First pain scores were self reported and subjective. Another limitation was patients were not given a specific medical cannabis dose and frequency for their pain and self titrated their product. Third, we had a very small sample of patients from one clinic with no control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franklin Caldera DO | University of Pennsylvania | 917 586 7742 | franklin.caldera@Pennmedicine.upenn.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 11, 2024 | Sep 18, 2025 | Prot_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064086 | Medical Marijuana |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline pain intensity using Numeric Pain Rating Scale | Pain intensity assessed using the Numeric Rating Scale where 0 = no pain and 10 = worst possible pain. | Mean | Standard Deviation | units on a 0-10 scale |
|
| Baseline opioid dose in Morphine milli-equivalents | Total daily opioid dose converted to morphine milligram equivalents | Mean | Standard Deviation | mg/day morphine equivalents |
|
| Rand Short Form 36 Questionaire | Health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36), a validated patient-reported questionnaire that assesses physical and mental health status. The SF-36 includes eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each domain score is transformed to a scale ranging from 0 to 100, where higher scores represent better health status and functioning, and lower scores represent worse | Mean | Full Range | Scores on a 0-100 scale |
|
|
|
| Primary | Change From Baseline to 5 Months in Daily Opioid Use (Morphine Milligram Equivalents) | 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. | Posted | Mean | 95% Confidence Interval | Morphine Milligram Equivalents (MME) | From Baseline to 5 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
Not provided
Not provided