An Early Phase 1 interventional study of CBD-dominant and THC dominant in Musculoskeletal Syndrome, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University of Minnesota · Early Phase 1, Interventional, and Supportive care
Aromatase inhibitors (AIs) are commonly used for post-menopausal women with hormone-positive breast cancer. Compared to tamoxifen, AIs improve breast cancer recurrence rates and lower 10-year breast cancer mortality. Unfortunately, nearly 2 out of 3 women with estrogen-receptor positive breast cancer treated with AIs experiences AIMSS, such as arthralgia, joint stiffness, and bone pain, and 30% of women with AIMSS report severe pain. AIMSS leads to poor adherence with therapy and discontinuation of therapy in up to 20% of patients. Despite the large number of women affected, current therapeutic interventions have shown only limited efficacy in improving AIMSS. Therefore, the presence of AIMSS may negatively impact breast cancer recurrence and survival. In this current trial, the plan is to utilize topical cannabinoid creams from Vireo Health that have been tested for potency and purity. Two distinct products with different THC/CBD ratios will be provided to patients at no cost; a) a THC-dominant cream (Red XS Balm with 375mg/jar and \<20mg of CBD) and b) a CBD-dominant cream (Violet Balm with 2210mg CBD/jar and \<0.3% THC). The study will explore the feasibility of doing larger, placebo controlled trials by first ensuring adequate patient interest, acceptable tolerability/safety of cream utilization, and preliminary efficacy measures. All patients completing assessments through day 14 will be allowed to choose either Red XS or Violet creams for an additional 2-week extension period.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Program (MMCP). This includes:
Exclusion Criteria:
Patients receiving CBD-dominant balm
Drug: CBD-dominant
Patients receiving THC-dominant balm
Drug: THC dominant
product contains 2210 mg CBD and less than 0.3% THC per 1.5 ounce jar. Patients will be provided a 2-week supply of creams (3 jars for each 14 day interval) by Vireo Health, according to the randomization arm. Patient will be instructed to apply the topical products using the 1.25cc spoon provided (there are approximately 35 scoops per 1.5oz jar). The patient will apply one scoop of cream to the back of each hand and then rub into the entire hand, wrist, and all fingers. After the 14 day assessment, patients will be transitioned to a two-week open label extension that allows them to choose their preference of either Red XS or Violet cream at no cost.
contains 375mg THC and less than 20mg CBD per 1.5 ounce jar. Patients will be provided a 2-week supply of creams (3 jars for each 14 day interval) by Vireo Health, according to the randomization arm. Patient will be instructed to apply the topical products using the 1.25cc spoon provided (there are approximately 35 scoops per 1.5oz jar). The patient will apply one scoop of cream to the back of each hand and then rub into the entire hand, wrist, and all fingers. After the 14 day assessment, patients will be transitioned to a two-week open label extension that allows them to choose their preference of either Red XS or Violet cream at no cost.
subject recruitment rate
percentage of participants actually recruited out of anticipated
Time frame: 4 weeks
subject retention rate
percentage of participants who completed the study
Time frame: 4 weeks
change in Brief Pain Inventory Short Form (BPI-SF) scores
worst pain, average pain, pain interference with general activity minimum value is zero equals no pain and maximum value is 10 equals pain as bad as you can imagine and the higher the score the worse the outcome.
Time frame: 2 weeks and 4 weeks
tolerability of topical medical cannabis creams
documenting patient adherence to dosing protocol through a Patient Topical Cannabis Dosing Diary. This is a document where the patient records the date, time, to which hands the dose was applied and if the dose was missed.
Time frame: 2 weeks and 4 weeks
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Minnesota