Dronabinol for Postoperative Pain

(dronabinol Trial)

RJ
Overseen ByRose Johnson
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Colorado Joint Replacement
Must be taking: Dronabinol
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

JM

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

I am a man who can father children and will use contraception.
I am willing and able to follow all study rules and attend all visits.
I am between 21 and 75 years old.
See 10 more

Exclusion Criteria

You are currently taking another experimental medication.
You have a documented mental illness like bipolar disorder or schizophrenia.
You have had allergic reactions to the ingredients in dronabinol.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Dronabinol or a placebo for 4 weeks post-operatively

4 weeks
Participants take study drug 2 times a day

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
Outcome measures collected at 4 and 6 weeks post-operative

What Are the Treatments Tested in This Trial?

Interventions

  • Dronabinol
  • Placebo
Trial Overview The trial tests if Dronabinol reduces painkiller needs after knee surgery compared to a placebo. Participants are randomly assigned to receive either Dronabinol or a placebo and their narcotic consumption post-surgery is monitored.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: dronabinolExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention

Dronabinol is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Marinol for:
🇺🇸
Approved in United States as Syndros for:
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Approved in Canada as REDUVO for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado Joint Replacement

Lead Sponsor

Trials
13
Recruited
3,300+

Published Research Related to This Trial

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.
Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.
The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials.Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]
In a clinical trial involving 240 multiple sclerosis patients over 16 weeks, dronabinol reduced neuropathic pain intensity by 1.92 points, similar to the 1.81 points reduction seen with placebo, indicating no significant difference in pain relief between the two treatments.
Dronabinol was found to be a safe long-term treatment option, with a higher rate of adverse reactions compared to placebo (50% vs. 25.9%), but these reactions decreased to 26% during extended use, and there were no significant signs of drug abuse or dependency.
Dronabinol Is a Safe Long-Term Treatment Option for Neuropathic Pain Patients.Schimrigk, S., Marziniak, M., Neubauer, C., et al.[2018]
Cannabis-derived medications like dronabinol and nabilone are effective for treating nausea and vomiting from chemotherapy and appetite loss in AIDS patients, while medical cannabis is commonly recommended for pain and muscle spasms, showing significant improvement in these conditions.
While the adverse effects of cannabis are generally mild, such as dizziness, there are serious safety concerns, particularly regarding adolescent use leading to increased schizophrenia risk and cognitive impairments, as well as risks of accidental ingestion in children.
The pharmacologic and clinical effects of medical cannabis.Borgelt, LM., Franson, KL., Nussbaum, AM., et al.[2022]

Citations

The Efficacy and Safety of Use of Cannabis and Cannabinoid ...(1.29% THC )7.13% reduction in pain compared to the placebo, and the (3.53% THC) treatment shows an approximate 0.35% reduction in pain compared ...
Cannabis and cannabidiol for postoperative pain ...For example, vaporized THC has demonstrated analgesic efficacy in neuropathic and musculoskeletal pain, whereas oral CBD alone has shown mixed or minimal ...
Perioperative Cannabinoids Significantly Reduce ...Our study found a 40% reduction in opioid use and a significantly greater improvement in LVEF in patients treated with adjunctive dronabinol.
Cannabis use and acute postoperative pain outcomes in ...This study investigates the association between preoperative cannabis use and postoperative pain outcomes, namely average pain score and total morphine ...
Cannabis use increases pain after surgery, study showsThe patients who used cannabis experienced 14% more pain during the first 24 hours after surgery compared to the patients who never used ...
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