Oral Cannabinoids for Chronic Pain

Overseen By Sonal Thaker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Methadone, Buprenorphine

Disqualifiers: Cannabis allergy, Serious medical issues, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of medical cannabis for managing chronic pain. Participants will use either CBD oil (MPL-001), a combination of CBD and THC oil (MPL-005), or a placebo oil for 12 weeks. The researchers aim to gather information to help design a larger study in the future. Individuals with chronic pain not caused by a life-threatening condition may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research in chronic pain management.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using Methadone or Buprenorphine. Also, you should not have used cannabis or similar products in the 30 days before joining the study.

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

Research has shown that CBD oil is usually safe for people, even in high amounts up to 1500 mg per day. Some individuals might experience side effects, but these are generally mild. However, more large studies are needed to fully understand its safety.

For CBD+THC oil, studies suggest this mix can help with pain and sleep. CBD might also reduce some of THC's negative effects, such as feeling high or anxious. However, the evidence for these benefits remains limited, and side effects can occur.

Overall, both treatments appear promising, but further research is necessary to confirm their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for chronic pain, which often include opioids and NSAIDs, the investigational treatments in this trial use cannabinoids, specifically CBD oil (MPL-001) and a combination of CBD and THC oil (MPL-005). Researchers are excited about these treatments because cannabinoids offer a new mechanism of action by interacting with the body's endocannabinoid system, which may provide pain relief with potentially fewer side effects than traditional pain medications. Additionally, the use of CBD and THC together might enhance the therapeutic effects, offering a broader spectrum of relief for chronic pain sufferers. This approach could potentially reduce reliance on opioids, which have significant addiction risks, making it a promising avenue for safer pain management.

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

Research has shown that using CBD oil alone can reduce chronic pain by 42% to 66% in many cases. However, most studies have found it is not more effective than a placebo, which contains no active ingredients. In this trial, participants will receive either CBD oil, CBD+THC oil, or a placebo oil. Some research suggests that combining CBD with THC (the active component of marijuana) can help with pain and sleep, showing similar pain reduction rates of 42% to 66%. Specifically, inhaling cannabis with both CBD and THC significantly relieved pain for some people, with 67.2% feeling better and 34.5% experiencing complete pain relief within two hours. Overall, while results vary, some evidence suggests these oils might help manage chronic pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Hance Clarke, MD, PhD

Principal Investigator

Toronto General Hospital, UHN

Are You a Good Fit for This Trial?

This trial is for adults over 25 who can read English and have chronic pain that isn't being managed by palliative care. It's not for those who've used cannabis products recently, have allergies to cannabinoids, serious health issues like heart or liver disease, uncontrolled mental disorders, are pregnant/breastfeeding, planning a family soon, or have alcohol/substance use disorder (except opioid use disorder).

Inclusion Criteria

I am 25 years old or older.

I have long-term pain that is not just for comfort.

Able to understand and read English

Exclusion Criteria

Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of child bearing potential during pretreatment evaluation)

I have not used nabilone, nabiximols, or cannabis in the last 30 days.

I plan to start a family soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBD oil, CBD+THC oil, or placebo for 12 weeks. The dose is adjusted based on efficacy and adverse effects.

12 weeks

Scheduled visits at 2, 4, 6, 8, and 12 weeks, either remotely or in-person

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBD oil ( MPL-001)
• CDB+THC oil (MPL-005)
• Placebo oil

Trial Overview The study tests the effectiveness and safety of medical cannabis in managing chronic pain. Over three months, participants will receive either CBD oil (MPL-001), a combination of CBD+THC oil (MPL-005), or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: CBD+THC oil Experimental Treatment 1 Intervention

Participants will receive CBD (cannabidiol) oil in combination with THC (delta-9-tetrahydrocannabinol) for a total duration of 12 weeks.

Group II: CBD oil Experimental Treatment 1 Intervention

Participants will receive CBD (cannabidiol) oil for a total duration of 12 weeks.

Group III: Placebo oil Placebo Group 1 Intervention

Participants will receive matching placebo oil for a total duration of 12 weeks.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37953193/

Effectiveness of Cannabidiol to Manage Chronic Pain The majority of the studies indicated pain reduction ranging from 42% - 66% with CBD alone and CBD with Tetrahydrocannabinol.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9288157/

Efficacy, Safety, and Regulation of Cannabidiol on Chronic Pain Medical Cannabis oil containing THC and CBD taken orally improves pain and sleep with direct or indirect effect on wound healing. Boehnke et al.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904223001935

Effectiveness of Cannabidiol to Manage Chronic Pain The majority of the studies indicated pain reduction ranging from 42% - 66% with CBD alone and CBD with Tetrahydrocannabinol.

4. jpain.org jpain.org/article/S1526-5900(23)00582-5/fulltext

Cannabidiol (CBD) Products for Pain: Ineffective ... Fifteen of the 16 RCTs were negative: no greater pain-relieving effect for CBD than for placebo. Meta-analyses link CBD to increased rates of serious adverse ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04729244

The Study of Hemp Oil CBD for Evaluation of Efficacy and ... The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, ...

6. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Many concerns have been raised about CBD use, particularly with regard to over-the-counter. CBD products, as there are limited data on their safety and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol Chronic use and high doses of up to 1500 mg per day have been repeatedly shown to be well tolerated by humans. Nonetheless, some side effects have been reported ...

8. bath.ac.uk bath.ac.uk/announcements/cbd-products-dont-ease-pain-and-are-potentially-harmful-new-study-finds/

CBD products don't ease pain and are potentially harmful There is no evidence that CBD products reduce chronic pain, and taking them is a waste of money and potentially harmful to health, new research finds.