What side effects are associated with this type of intervention?

Topical cannabinoid creams, such as those containing THC and CBD, are generally well-tolerated with few reported adverse effects. Common side effects may include localized skin reactions like redness, itching, or irritation. Systemic side effects are rare but can include dizziness, dry mouth, and fatigue, particularly with higher THC concentrations. These treatments are being explored for their potential to reduce pain and inflammation in conditions like Musculoskeletal Syndrome by interacting with the endocannabinoid system.

What prior FDA approvals exist?

The FDA has not specifically approved topical cannabinoid creams for the treatment of Musculoskeletal Syndrome. However, cannabinoids like THC and CBD have been explored for their potential to reduce pain and inflammation by interacting with the endocannabinoid system. While there are no FDA-approved topical cannabinoid treatments for this condition, other cannabinoid-based pharmaceuticals such as dronabinol and nabilone have been approved for different indications, including chronic severe pain and chemotherapy-induced nausea and vomiting. These approvals highlight the therapeutic potential of cannabinoids, although more research is needed to establish their efficacy and safety for Musculoskeletal Syndrome.

What other types of research exist?

Promising novel alternatives to topical cannabinoid creams for musculoskeletal syndrome include: 1) Topical formulations containing palmitoylethanolamide (PEA), which has shown anti-inflammatory effects. 2) Nonsteroidal anti-inflammatory drug (NSAID) gels or creams, which are commonly used for localized pain relief. 3) Glucocorticoid (steroid) injections for targeted relief of inflammation and pain. 4) Herbal preparations such as Capsicum frutescens (cayenne) and Symphytum officinale (comfrey root extract), which have shown some efficacy in pain management. 5) Physical therapy and exercise programs tailored to improve joint function and reduce pain.

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Cannabinoid

Topical Cannabinoids for Musculoskeletal Syndrome

Phase < 1

Waitlist Available

Led By Anne Blaes, MD,MS

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks and 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests cannabinoid creams to help post-menopausal women with hormone-positive breast cancer who suffer from joint pain due to their treatment. The creams, one with more THC and the other with more CBD, aim to reduce pain and improve comfort. Researchers will check if patients are interested, if the creams are safe, and if they work well.

Who is the study for?

This trial is for adults in Minnesota with hormone receptor-positive breast cancer who have been on aromatase inhibitors for at least 60 days and are experiencing joint pain from the treatment. Participants must be willing to join the Minnesota Medical Cannabis Program, not use other cannabinoids recently, and not plan to start new pain medications or therapies like acupuncture during the study.

What is being tested?

The CanAroma study tests two topical cannabinoid creams: one THC-dominant and one CBD-dominant, provided by Vireo Health. The goal is to see if these creams are safe, tolerated well, and effective against joint pain caused by breast cancer medication (AIMSS). It's a preliminary step towards larger trials.

What are the potential side effects?

Potential side effects may include skin irritation where the cream is applied or allergic reactions if sensitive to cannabinoids. Since it's a topical treatment, systemic side effects are less likely but could still occur depending on individual absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks and 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks and 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

subject recruitment rate

subject retention rate

Secondary study objectives

change in Brief Pain Inventory Short Form (BPI-SF) scores

tolerability of topical medical cannabis creams

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: VioletExperimental Treatment1 Intervention

Patients receiving CBD-dominant balm

Group II: Red XsExperimental Treatment1 Intervention

Patients receiving THC-dominant balm

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Topical cannabinoid creams, such as those containing THC and CBD, are thought to interact with the endocannabinoid system, which plays a role in regulating pain and inflammation. THC primarily activates CB1 receptors in the central nervous system, leading to pain relief, while CBD interacts with CB2 receptors found in the immune system, reducing inflammation. This dual mechanism can be particularly beneficial for patients with Musculoskeletal Syndrome, as it addresses both pain and inflammation, which are key symptoms of the condition. Other common treatments, such as NSAIDs, also target inflammation but may not provide the same level of pain relief or have the same safety profile as cannabinoids. Therefore, cannabinoid creams offer a promising alternative for managing symptoms and improving adherence to therapy.

Attenuation of persistent pain-related behavior by fatty acid amide hydrolase (FAAH) inhibitors in a rat model of HIV sensory neuropathy.Characterization of delta9-tetrahydrocannabinol and anandamide antinociception in nonarthritic and arthritic rats.