Dronabinol for Postoperative Pain
(dronabinol Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether dronabinol, a medication derived from cannabis, can reduce the need for narcotics in people recovering from knee replacement surgery. Participants will receive either dronabinol or a placebo (a pill with no active drug) without knowing which one they are taking. It suits individuals scheduled for a single knee replacement surgery who have not recently used narcotics or cannabis. The goal is to determine if dronabinol can ease pain without the side effects of stronger painkillers. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking pain management solutions.
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used narcotics in the past 6 weeks or cannabis regularly in the past 3 months. Also, you must be able to take the standardized pain medications like Tylenol, gabapentin, and meloxicam.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dronabinol, a type of synthetic cannabinoid, has undergone safety testing in people. One study found that patients using dronabinol reduced their opioid use by 40% without major safety concerns, suggesting that dronabinol might be safe for most people.
Dronabinol is already FDA-approved for other uses, indicating that its safety is generally well understood. However, individual reactions can vary, and some have reported increased pain after surgery when using cannabinoids. These mixed results underscore the importance of discussing any side effects during the trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about dronabinol for postoperative pain because it offers a novel approach compared to standard pain treatments like opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Dronabinol is a synthetic form of THC, the active compound found in cannabis, which may offer pain relief with a potentially lower risk of addiction and fewer side effects than traditional opioids. Unlike other treatments that primarily target inflammation or block pain signals, dronabinol interacts with the body's endocannabinoid system, potentially providing a unique pathway for managing pain. This distinct mechanism of action could make it a valuable alternative for patients seeking effective pain management with reduced reliance on opioids.
What evidence suggests that Dronabinol might be an effective treatment for postoperative pain?
Research has shown that dronabinol, a compound from cannabis, might reduce the need for strong painkillers after surgery. One study found that dronabinol use led to a 40% decrease in opioid consumption, which are often prescribed for postoperative pain relief. This trial will compare dronabinol to a placebo to evaluate its effectiveness in managing postoperative pain. Although some research on cannabis shows mixed results, dronabinol specifically has shown promise in reducing pain and the need for opioids. This could lead to less reliance on traditional painkillers, which can have serious side effects.12345
Who Is on the Research Team?
Jason Jennings, MD
Principal Investigator
Colorado Joint Replacement
Are You a Good Fit for This Trial?
This trial is for adults aged 21-75 undergoing knee replacement at Colorado Joint Replacement who can take oral meds and follow the study plan. They must not have used narcotics in the last 6 weeks, cannabis regularly in the past 3 months, or tobacco recently. No history of major mental disorders, seizures, drug/alcohol abuse, or allergies to dronabinol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dronabinol or a placebo for 4 weeks post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dronabinol
- Placebo
Dronabinol is already approved in United States, Canada for the following indications:
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- Sleep apnea
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado Joint Replacement
Lead Sponsor