Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 2:30 AM
Study NCT ID:
NCT07194928
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Cannabis as an Opiate Alternative
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Medical Cannabis as an Opiate Alternative
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 and McGill Pain Questionnaire, which measures sensory, affective and evaluative dimensions of pain prior to receiving medical marijuana and then at 6 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 marijuana 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 six 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 six months the physician will recheck a urine drug screen, current pain level and readminister the McGill Pain Questionnaire and Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
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 and McGill Pain Questionnaire, which measures sensory, affective and evaluative dimensions of pain prior to receiving medical marijuana and then at 6 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 marijuana 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 six 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 six months the physician will recheck a urine drug screen, current pain level and readminister the McGill Pain Questionnaire and Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: