RecruitingPHASE2INTERVENTIONAL

Cannabidiol After Multi-Trauma for Pain and Opioid Therapy

This research is investigating if a cannabis-based medicine called Cannabidiol (CBD) can help people who have suffered a fracture. The main goal is to see if CBD can reduce pain and inflammation after a broken bone injury, making recovery easier. Researchers also want to find out if taking CBD means patients need fewer strong painkillers, like opioids, which can be addictive. The study will look at two different doses of CBD compared to a dummy pill (placebo) over one month. They will also check how CBD affects sleep, mood, quality of life, and bone healing. This study aims to help reduce long-term pain and promote better recovery for trauma patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Enrolment target

225

Start

01 Jun 2025

Estimated completion

01 Jun 2027

Fracture

What is this study about?

When you have a serious injury like a broken bone, it's very common to experience a lot of pain. Sometimes, this pain can even last for a long time, becoming what's known as chronic pain. This happens because the injury can cause inflammation in your body, and sometimes this inflammation can affect your nervous system, making the pain stick around.

This study is looking at a medicine called Cannabidiol, or CBD for short. CBD comes from the cannabis plant, but it’s important to know that it doesn't cause a 'high' or have addictive effects, unlike other parts of the plant. Scientists are interested in CBD because it's thought to help with pain and inflammation. It might also help protect your nervous system from the effects of injury and even improve how bones heal.

The main idea behind this research is to see if giving CBD shortly after a broken bone injury can help reduce pain and stop chronic pain from developing. Researchers also want to see if CBD can help people manage their pain with fewer strong, addictive painkillers called opioids. By doing this, they hope to help people recover better and faster after a major injury.

Key takeaways

This study is testing CBD for pain relief and recovery after broken bones.
CBD is non-addictive and does not cause a 'high'.
It aims to reduce reliance on strong opioid painkillers.
The study compares two CBD doses to a dummy pill (placebo).
It lasts for one month, with follow-up monitoring.
Common side effects can include sleepiness or fatigue.

Who may be eligible?

To be part of this study, you need to be between 18 and 70 years old and have recently broken a bone in your arm or leg. This means bones like your shin, thigh, forearm, or hand bones. You can be included whether or not you've had surgery for your break.

There are certain reasons why you wouldn't be able to join. For example, if you have a severe head injury, certain mental health conditions like schizophrenia or untreated sleep problems, or a history of alcohol or drug misuse. Also, if you have severe kidney or liver problems, or if you're pregnant, breastfeeding, or planning to get pregnant, you can't take part.

Other reasons that would prevent you from joining include having reacted badly to cannabis before, taking certain medications like warfarin, or if you had little to no pain in the 24 hours before thinking about joining. People who regularly use cannabis more than 5 times a week, or those with existing long-term pain conditions, bone diseases, or chronic inflammatory diseases like rheumatoid arthritis, are also unable to participate. You must also be able to speak either French or English.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you recently broken a bone in your arm or leg (within the last week)?
Do you have moderate or severe pain from your injury?
Do you have any severe kidney or liver problems?
Are you pregnant, breastfeeding, or planning to get pregnant?
Can you speak French or English?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either CBD (Cannabidiol) at one of two different doses, or a placebo (a dummy pill with no active medicine). You will take this treatment every day for one month. During this time, you will have several visits where doctors and nurses will check how you're feeling, measure your pain levels, and ask questions about your sleep, mood, and daily activities. They will also check for any side effects. You'll need to answer questionnaires about your quality of life. The study also includes checking markers of inflammation and how your bone is healing. The total time you'll be involved in the study will extend beyond the one month of treatment, as researchers will follow up on your progress.

Potential risks and benefits

A potential benefit of joining this study is that CBD might help reduce your pain and inflammation after a broken bone, potentially lessening your need for strong opioid painkillers and speeding up your recovery. It could also improve your mood and sleep. CBD is generally considered safe, but like all medicines, it can have side effects. The most common ones are feeling sleepy, tired, or having a reduced appetite. You will have access to emergency doctors throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hôpital Sacré-Coeur de Montréal
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Cannabidiol (CBD)?

CBD is a substance found in the cannabis plant. Unlike other parts of cannabis, CBD does not cause a 'high' and is not addictive. It's being studied for its potential to help with pain and inflammation.

What does 'placebo-controlled' mean?

This means some people in the study will get the actual CBD medicine, and others will get an identical-looking dummy pill (placebo) that contains no active medicine. This helps researchers see if the CBD is truly having an effect, rather than just the expectation of feeling better.

Will I become addicted to CBD?

No, CBD itself is not considered addictive and does not have the intoxicating or 'high' effects associated with other components of the cannabis plant.

How long will I be taking the medication?

If you participate, you will be taking the study medication (either CBD or placebo) every day for one month.

Will this study affect my usual pain medication?

The study aims to see if CBD can reduce the need for strong pain medications like opioids. Your doctors will monitor your pain and medication closely throughout the study.

How to find out more

Louis De Beaumont, PhD

louis.de.beaumont@umontreal.ca 514-338-2222 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.