Chronic PainNCT07194928
Medical Cannabis as an Opiate Alternative
An observational study of Chronic Pain and Opioid Use, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use
- What is being tested?
- We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- History of Schizophrenia
- Acute psychiatric disorder
- Licensed to carry firearm
- Federal job that excludes them from receiving medical marijuana.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19146
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Opioid Use
- Being tested
- We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.
- Keywords
- Chronic pain, Opioid medication, Medical Marijuana
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.Other
Also called Medical cannabis
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Sep 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin Caldera, University of Pennsylvania
- Investigators
- Franklin E Caldera, DO,MBA, Principal investigator, Univeristy of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194928
- Sponsor's protocol ID
- 856134
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2025
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We only use non identifiable data and do not plan to use any identifiable individual data.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Cannabis as an Opiate Alternative
- ClinicalTrials.gov ID
- NCT07194928
- Acronym / sponsor ID
- 856134
- Conditions
- Chronic Pain, Opioid Use
- Keywords
- Chronic pain, Opioid medication, Medical Marijuana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic opioid pain patients were cost was barrier to trying medical marijuana | – | Other: We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- History of Schizophrenia
- Acute psychiatric disorder
- Licensed to carry firearm
- Federal job that excludes them from receiving medical marijuana.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.Also: Medical cannabisWe 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 | Other | Chronic opioid pain patients were cost was barrier to trying medical marijuana |
Primary outcome
Change in Mean Numeric Rating Scale at 5 Months From Baseline
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We only use non identifiable data and do not plan to use any identifiable individual data.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin E Caldera, DO,MBA principal investigator
Univeristy of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Opioid Use, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Numeric Rating Scale at 5 Months From Baseline (time frame: From enrollment monthly until the end of treatment at 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.