Topical Cannabis for Chronic Musculoskeletal Pain

NCT ID: NCT05908552

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-08-31

Brief Summary

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

Detailed 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.

Conditions

Chronic Pain; Musculoskeletal Pain; Joint Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Lindley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Rachael Rzasa Lynn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Central Contacts

Emily Lindley, PhD

Role: CONTACT

CUPainStudies@cuanschutz.edu

3037240923

Alan Morris, PhD

Role: CONTACT

CUPainStudies@cuanschutz.edu

3037240923

Other Identifiers

25B2360

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-1289

Identifier Type: -

Identifier Source: org_study_id