Medical Cannabis as an Opiate Alternative

NCT07194928 | Completed Results

• 1 other identifier: 856134
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Chronic Pain

Keywords

Chronic pain; Opioid medication; Medical Marijuana

Outcome Measures

Primary Outcomes (2)

• 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

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'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

Also known as: Medical cannabis

Chronic opioid pain patients were cost was barrier to trying medical marijuana

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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 cannabis 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 and cost prohibited from trialing in the past

You may not qualify if:

• History of Schizophrenia
• Acute psychiatric disorder
• Licensed to carry firearm
• Federal job that excludes them from receiving medical marijuana.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Franklin Caldera DO
• Organization: University of Pennsylvania

franklin.caldera@Pennmedicine.upenn.edu

917 586 7742

Study Officials

• Franklin E Caldera, DO,MBA

  Univeristy of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 20, 2026
• Results First Posted: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)