Cannabis for Multiple Sclerosis

Overseen By Sarah A Morrow, MD, MS, FRCPC, FAAN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Calgary

Must not be taking: Antipsychotics, Benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, Dementia, Seizure, 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: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how components of cannabis, specifically THC and CBD, can aid thinking skills and bladder issues in people with Multiple Sclerosis (MS). Participants will take either THC or CBD oil once daily for 15 weeks. The study aims to determine if these cannabis oils can improve MS-related symptoms. Suitable candidates have been diagnosed with MS and experience bladder problems affecting daily life. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medication for bladder symptoms, you must have been stable on it for at least 4 weeks. You cannot participate if you use antipsychotic medications or certain other drugs like benzodiazepines during the day.

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

Research has shown that THC and CBD, the main components of cannabis, have been studied for their safety in treating multiple sclerosis (MS). One study on THC found no major safety concerns, although some participants experienced dizziness, dry mouth, and urinary issues. These side effects occurred more frequently in those using cannabis compared to non-users.

CBD also showed no major safety concerns in studies and was found to be safe and well-tolerated. Participants reported reduced pain, muscle stiffness, and sleep problems. Both THC and CBD have been used in MS patients without significant safety issues. However, some side effects can occur, so monitoring how one feels during treatment is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabis for multiple sclerosis because it offers a novel approach by tapping into the therapeutic potential of cannabinoids like THC and CBD. Unlike traditional treatments that often focus on immune modulation or symptom relief through drugs like interferons and glatiramer acetate, THC and CBD target the endocannabinoid system, which may help manage pain, spasticity, and inflammation in a more holistic way. THC is known for its psychoactive effects and potential for relieving pain and muscle spasticity, while CBD is non-psychoactive and may reduce inflammation and anxiety. This dual approach could provide a broader range of benefits with fewer side effects compared to current standard therapies.

What evidence suggests that this trial's treatments could be effective for Multiple Sclerosis?

This trial will compare the effects of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) on symptoms of Multiple Sclerosis (MS). Research suggests that cannabis, including THC and CBD, might alleviate some MS symptoms. Participants in one trial arm will receive THC, which may reduce muscle stiffness and tightness, though it seems less effective for bladder issues. Another group will receive CBD, which might help with tiredness, pain, and muscle tightness, potentially improving movement for some with MS. While both THC and CBD show promise in managing certain MS symptoms, their effectiveness can vary. More research is needed to fully understand their impact on thinking and bladder problems in MS. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Multiple Sclerosis who have bladder symptoms scored at least 7 on the NBSS. They must use contraception if applicable, agree to study terms, and have a stable medication routine for bladder issues if they're already being treated.

Inclusion Criteria

I have been on the same NLUTD medication for at least 4 weeks.

I have been diagnosed with Multiple Sclerosis.

I have symptoms of bladder dysfunction with a score of 7 or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either THC or CBD oil and will take the study drug for 15 weeks

15 weeks

3 visits (in-person) at baseline, week 10, and week 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis (THC vs. CBD)

Trial Overview

The trial tests how THC or CBD oils affect cognition and bladder control in MS patients over 15 weeks. Participants will be randomly given either oil and complete cognitive tests and questionnaires throughout the study.

How Is the Trial Designed?

Group I: Tetrahydrocannabinol (THC) 25 mg Experimental Treatment 1 Intervention

THC oil will be administered orally once a day for 15 weeks.

Group II: Cannabidiol (CBD) 50 mg Experimental Treatment 1 Intervention

CBD oil will be administered orally once a day for 15 weeks.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Multiple Sclerosis Society of Canada

Collaborator

Trials

17

Recruited

990+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5874292/

Cannabidiol to Improve Mobility in People with Multiple ...

It is our opinion that CBD supplementation maybe advisable for PwMS to reduce fatigue, pain, spasticity, and ultimately improve mobility.

2.

ijmsc.org

ijmsc.org/view/multiple-sclerosis-and-use-of-medical-cannabis-a-retrospective-review-of-a-neurology-outpatient-population

Multiple Sclerosis and Use of Medical Cannabis

Results: Patients experienced extensive MS symptom improvement after initiation of MC, with alleviation of pain (72% of patients) and spasticity ...

3.

nationalmssociety.org

nationalmssociety.org/managing-ms/treating-ms/integrative-medicine/medical-cannabis

Medical Cannabis for MS Management

However, reviews of published studies have shown that synthetic, non-inhaled cannabinoids may provide a modest benefit in controlling pain and spasticity. Less ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714425002654?via%3Dihub

Evaluating the effect of cannabidiol on sleep quality in ...

This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of ...

5.

asra.com

asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2024/11/06/cannabis-in-the-management-of-multiple-sclerosis-related-pain-and-spasticity

Cannabis in the Management of Multiple Sclerosis-Related ...

The Multiple Sclerosis Extract of Cannabis trial demonstrated a twofold increased rate of relief from muscle stiffness with oral cannabis ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1739436/

Cannabinoids in multiple sclerosis (CAMS) study

There were no major safety concerns. Overall, patients felt that these drugs were helpful in treating their disease. Conclusions: These data provide limited ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2211034820307823

Safety and efficacy of low-dose medical cannabis oils in ...

Treatment with medical cannabis oils was safe and well tolerated, and resulted in a reduction in pain intensity, spasticity and sleep disturbances in MS ...