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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

Research Team

W Steigleman, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+