Cannabinoid vs Opioid for PRK Pain Control

Overseen By Shannon Hampton

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Tricyclics, Gabapentin, Tramadol, others

Disqualifiers: Pregnancy, Nursing, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medications to manage pain after photorefractive keratectomy (PRK), a type of eye surgery that often causes significant pain. One group will use a traditional painkiller containing codeine and acetaminophen, while the other will try a cannabinoid, a compound found in cannabis. The researchers aim to determine if the cannabinoid can control pain as effectively as the opioid-based medication. Individuals with stable vision for a year who plan to undergo PRK surgery on both eyes may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in pain management.

Do I need to stop my current medications to join the trial?

Yes, if you are taking other pain medications like tricyclic antidepressants, gabapentin, or tramadol, you will not be able to join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oral cannabinoids are generally safe for use. Users have reported mild side effects, such as dizziness or dry mouth, which are typically not serious. Studies have not identified any severe side effects.

In contrast, the combination of codeine and acetaminophen is an approved pain treatment. It is effective but may cause side effects like drowsiness, constipation, and nausea. These side effects are well-known and can usually be managed with a doctor's assistance.

In summary, both treatments have been used in people and are considered safe, with known side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using oral cannabinoids for pain control after PRK (photorefractive keratectomy) because they offer a novel approach compared to traditional opioid treatments like codeine. Unlike opioids, which can cause dependency and a host of side effects, cannabinoids work by interacting with the body's endocannabinoid system, potentially offering effective pain relief with a different safety profile. This alternative mechanism may provide pain relief with fewer addictive properties and side effects, making it an appealing option for patients undergoing PRK.

What evidence suggests that this trial's treatments could be effective for PRK pain control?

Research has shown that cannabinoids, especially CBD (a substance found in cannabis), might help manage pain. Some studies suggest that CBD could relieve pain as effectively as traditional opioid medications like codeine. This trial will compare the effectiveness of oral cannabinoids with oral codeine/acetaminophen for managing pain after PRK surgery, which can be very intense. Although opioids are usually used for this type of pain, researchers are considering CBD as an alternative due to its potential for fewer side effects and a lower risk of addiction. Early results appear promising, but further research is necessary for confirmation. ^{1 2 3 5 6}

Who Is on the Research Team?

W Steigleman, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have stable near-sightedness or farsightedness and choose to undergo Photorefractive Keratectomy (PRK) surgery. Participants must consent to the study and can't be excluded based on other criteria not listed here.

Inclusion Criteria

Consenting to participate

Not meeting exclusion criteria will be included in the study population.

Exclusion Criteria

I am aware using the cannabinoid product might make me fail a drug test.

Known or suspected allergy or hypersensitivity to any of the routine or study medications

I am not a candidate for PRK eye surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PRK in each eye sequentially, using cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of corneal haze, visual acuity, and pain

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oral Cannabinoid
• Oral CBD
• Oral Codeine/Acetaminophen

Trial Overview The study compares pain control methods after PRK surgery: one eye will receive an oral cannabinoid for pain, while the other eye will get a codeine/acetaminophen combination two weeks later. This allows patients to experience both treatments.

How Is the Trial Designed?

Group I: Oral cannabinoid Experimental Treatment 1 Intervention

Oral cannabinoid

Group II: Oral codeine/acetaminophen Active Control 1 Intervention

Oral codeine-acetaminophen for controlling pain

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Consortium for Medical Marijuana Clinical Outcomes Research

Collaborator

Trials

5

Recruited

100+

Consortium for Medical Marijuana Clinical Outcomes Research

Collaborator

Trials

3

Recruited

70+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/75/NCT05477875/Prot_000.pdf

zProtocol Published evidence suggests that hemp-based cannabidiols (CBD) may be a suitable pain-control alternative, and we propose this study to evaluate ...

2. ufhealth.org ufhealth.org/clinical-trials/cbd-vs-opioid-for-prk-pain-control

CBD vs Opioid for PRK Pain Control Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration.

3. withpower.com withpower.com/trial/phase-2-photorefractive-keratectomy-8-2022-10776

Cannabinoid vs Opioid for PRK Pain Control Trial Overview The study compares pain control methods after PRK surgery: one eye will receive an oral cannabinoid for pain, while the other eye will get a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05477875

Study Details | NCT05477875 | Cannabinoid vs Opioid for ... Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are ...

5. mmjoutcomes.org mmjoutcomes.org/media/mmj/medicament/MEDICAMENT-Fall-2022.pdf

MEDICAMENT In this study, we will evaluate if an oral CBD product can offer similar pain relief to current standard therapy with an opioid medication.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0886335014010062

Efficacy and safety of pain relief medications after ... Review/Update. Efficacy and safety of pain relief medications after photorefractive keratectomy: Review of prospective randomized trials.