NCT07194928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 11, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

Chronic painOpioid medicationMedical Marijuana

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale (VAS)

    The patient will follow up monthly and have their pain score evaluated monthly morphine, at 1st visit 3rd visit and 6th visit patient will be given McGill Pain evaluation and Short form- 36 questionaire.

    6 months

  • Morphine equivalents

    The patient will follow up monthly for 6 months and have their morphine equivalent dosing monitored.

    6 months

  • McGill Pain evaluation

    The patient will follow up monthly but McGill Pain questionnaire will be administered at 1st month, 3rd month and 6th month visits.

    1st month, 3rd month and 6th month

  • Short form-36 questionnaire.

    The patient will follow up monthly but Short Form 36 questionnaire will be administered at 1st month, 3rd month and 6th month visits.

    1st month, 3rd month and 6th month

Study Arms (1)

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.

Other: We will monitor patient's response to medical marijuana as alternative to opioid for chronic pain.

Interventions

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

Also known as: Medical cannabis
Chronic opioid pain patients were cost was barrier to trying medical marijuana

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic pain patient on long term opioids who failed to wean off in the past. Patients have no contraindication to medical marijuana and qualify to try as an alternative to opioids.

You may qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 26, 2025

Study Start

October 11, 2024

Primary Completion

June 6, 2025

Study Completion

June 6, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

We only use non identifiable data and do not plan to use any identifiable individual data.

Locations