Clinical trial NCT05908552: Topical Cannabis for Chronic Musculoskeletal Pain
Official title: A Novel Non-Opioid Topical Therapy for Chronic Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Musculoskeletal Pain
Joint Pain
Keywords: topical
cannabis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 77
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic pain of the peripheral joints (such as knee, ankle, and shoulder) who are interested in initiating use of a topical cannabinoid will be recruited.

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.

Eligibility 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

Primary outcomes:
measure: Change in in PROMIS Pain Interference Score from Baseline to 2 months
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Levels of plasma cannabinoid and cannabinoid metabolites
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Opioid and non-opioid pain medications use
timeFrame: Daily through 2 weeks
measure: Reported drug effects
timeFrame: Baseline, 4 hours, 24 hours, 2 weeks, 2 months
measure: Change in in PROMIS Pain Intensity Score from Baseline to 2 months
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile from Baseline to 2 months
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Change in Patients' Global Impression of Change (PGIC) from Baseline to 2 Months
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Change Patient Specific Functional Scale from Baseline to 2 Months
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Change in NIH Toolbox® List Sorting Working Memory Test from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in NIH Toolbox® Oral Symbol Digit Test from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in NIH Toolbox® Flanker Inhibitory Control and Attention Test from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in NIH Toolbox® Pattern Comparison Processing Speed Test from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in NIH Toolbox® Picture Vocabulary Test from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in Fine Motor Function from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Change in Gross Motor Function from Baseline to 2 Weeks
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
measure: Abuse liability
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Participant Treatment Expectations and Impressions
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Participant Perceived Efficacy
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Participant Preference vs Other Analgesics
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Participant Reported Adverse Effects
timeFrame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
measure: Half life analysis of cannabinoid and cannabinoid metabolites
timeFrame: baseline through 2 weeks
measure: Clearance analysis of cannabinoid and cannabinoid metabolites
timeFrame: baseline through 2 weeks
measure: Volume of distribution analysis of cannabinoid and cannabinoid metabolites
timeFrame: baseline through 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Emily Lindley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Rachael Rzasa Lynn, MD
role: PRINCIPAL_INVESTIGATOR
References: