Topical Cannabis for Chronic Musculoskeletal Pain

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Musculoskeletal Pain; Joint Pain; Chronic Pain

Study type: Observational

Funder types: Other

Identifiers

NCT05908552

22-1289

25B2360 (Other Grant/Funding Number)

Details and patient eligibility

About

Our proposal objective is to evaluate if state-regulated topical CBD-based products relieve chronic musculoskeletal pain and/or absorb into the bloodstream.

Full description

The goal of this study is to learn more about the analgesic efficacy of state-regulated topical cannabinoid products (creams, lotions, salves, etc) and to determine if these topical products are absorbed systemically and can be detected in blood samples. Given that state-regulated dispensary products cannot be brought onto the university campus, this observational study design utilizes a Mobile Pharmacology Laboratory that will go to study participants' homes. Blood samples and other assessments will taken in the mobile lab prior to use of a topical cannabinoid product and at several time points afterwards (4 hours, 24 hours, and 2 weeks). Participants will also collect microsamples of blood using a small device at home at three time points during the first 2-72 hours after application of the product.

Enrollment: 77 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Inclusion Criteria:

• Chronic peripheral joint pain
• Desire and intent to use a topical cannabinoid product containing cannabidiol (CBD) or a combination of CBD and tetrahydrocannabinol (THC) to alleviate this pain

Exclusion Criteria:

• Current or prior use of topical cannabis
• Unwilling or unable to discontinue other (non-topical) cannabis use for four weeks prior to and during study participation through week two
• Intent to use a THC-predominant topical product (ratio greater than 1:1 of THC to CBD)
• Current or history of substance use disorder
• History or diagnosis of schizophrenia, bipolar or a psychotic disorder
• Surgery on the affected musculoskeletal location within the 3 months prior to enrollment
• Planned surgery or procedure on the affected musculoskeletal location during participation in the study
• Allergy or prior severe adverse reaction to cannabis (cardiovascular event, psychosis, etc)
• Current or prior cannabis abuse/dependence
• Cognitive disability that interferes with ability to provide consent or understand study procedures
• History of seizure disorder
• Pending legal action or workers compensation
• Pregnant females or females intending to become pregnant during the study period
• Lactating females
• Chronic/severe medical illness (renal disease, liver disease, cancer, significant cardiovascular disease, or history of myocardial infarction)
• Active component military