Topical Cannabis for Chronic Musculoskeletal Pain

June 9, 2023 updated by: University of Colorado, Denver

A Novel Non-Opioid Topical Therapy for Chronic Musculoskeletal Pain

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in in PROMIS Pain Interference Score from Baseline to 2 months
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The PROMIS Pain Interference (Short Form 6a) includes 6 items that assess the self-reported consequences of pain on various aspects of life including social, cognitive, emotional, physical and recreational activities. Participants rate these consequences on a Likert Scale that ranges from 1 (Not at all) to 5 (Very much). The scores are then converted to T-scores, with higher values indicating greater pain interference.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Levels of plasma cannabinoid and cannabinoid metabolites
Time Frame: Baseline to 2 weeks
Four venous blood samples will be obtained at baseline, 4 hours, 24 hours, and 2 weeks after first use of the selected topical cannabinoid.
Baseline to 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid and non-opioid pain medications use
Time Frame: Daily through 2 weeks
Participant self-report of opioid and non-opioid analgesic use
Daily through 2 weeks
Reported drug effects
Time Frame: Baseline, 4 hours, 24 hours, 2 weeks, 2 months
Subjective ratings of psychoactive effects ("high,'' ''impaired,'' ''stoned,'' ''like the drug effect,'' ''sedated,'' ''confused,'' ''nauseated,'' ''desire more of the drug,'' ''anxious,'' ''down,'' ''hungry,'') measured on a 100-mm VAS
Baseline, 4 hours, 24 hours, 2 weeks, 2 months
Change in in PROMIS Pain Intensity Score from Baseline to 2 months
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The PROMIS Pain Intensity (Short Form 3a) includes 3 items that assess how much a person hurts. The first two items assess pain intensity using a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patients to rate their pain intensity "right now." Participants rate their pain on a Likert Scale that ranges from: 1 (Had no pain) to 5 (Very severe).
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile from Baseline to 2 months
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The PROMIS-29 Profile assesses physiological, social, and psychological outcomes using a comprehensive set of biopsychosocial domains. These domains include physical function, anxiety, depression, fatigue, sleep, ability to participate in social roles and/or activities, pain interference, and pain intensity. The questionnaire responses are ranked on a 5-point Likert Scale, and pain intensity is rated on an 11-point scale. Higher scores reflect a greater presence of the measured domain. For symptom-oriented domains (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores indicate more severe symptomatology, while for function-oriented domains (physical functioning and social role), higher scores indicate better functioning. For instance, a high sleep disturbance score indicates significant levels of sleep disruption, whereas a high physical functioning score indicates better physical capabilities.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Change in Patients' Global Impression of Change (PGIC) from Baseline to 2 Months
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The Patient Global Impression of Change (PGIC) is a self-report measure used in chronic pain clinical trials to assess a patient's perception of treatment efficacy. The PGIC uses a 7-point scale where patients rate their overall improvement, ranging from "very much improved" to "very much worse."
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Change Patient Specific Functional Scale from Baseline to 2 Months
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
The Patient Specific Functional Scale is an 11-point scale where "0" represents "unable to perform activity" and "10" represents "Able to perform activity at the same level as before injury or problem". Participants rate their ability to perform up to five important activities that they find difficult due to their musculoskeletal pain.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Change in NIH Toolbox® List Sorting Working Memory Test from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Test of working memory - the capacity of an individual to hold information in a short-term buffer and manipulate the information. All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 4 hour, 24 hour, 2 week time-points to baseline.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Oral Symbol Digit Test from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency. All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 4 hour, 24 hour, 2 week time-points to baseline.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Flanker Inhibitory Control and Attention Test from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Test of executive function - the capacity to plan, organize and monitor the execution of behaviors that are strategically directed in a goal-oriented manner) and attention (allocation of one's limited capacities to deal with an abundance of environmental stimulation) test. All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 4 hour, 24 hour, 2 week time-points to baseline.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Pattern Comparison Processing Speed Test from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency. All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 4 hour, 24 hour, 2 week time-points to baseline.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Picture Vocabulary Test from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Test of vocabulary knowledge. All cognitive data will be represented by raw scores and T scores. We will assess changes over time in patients comparing their 4 hour, 24 hour, 2 week time-points to baseline.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in Fine Motor Function from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
The Grooved Pegboard Test will be used to test fine motor function. The manipulative dexterity test described in the protocol consists of a board with twenty-five holes containing randomly positioned slots and pegs. The pegs have a key along one side and must be rotated to match the corresponding hole before insertion. This test evaluates the speed of performance in a fine motor task and assesses both sides of the body.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in Gross Motor Function from Baseline to 2 Weeks
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in Gross Motor Function will be assessed by the DRiving Under the Influence of Drugs (DRUID)® tests and Components of the Field Sobriety Tests, including One-Leg Stand, Walk-and-Turn, Modified Romberg Balance. The DRUID® tests measure impairment based on performance of various tasks. Scores range from 0-100, where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = "impaired"; <13-point change (from baseline) = "not impaired". Two or more clues noted during the field sobriety tests indicate impairment.
Assessed at baseline, 4 hours, 24 hours, 2 weeks
Abuse liability
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Craving visual analog scale (VAS): Assesses craving for topical cannabinoid on a 100mm visual scale. Drug Effects Questionnaire (DEQ): Assesses the strength of the topical cannabinoid effect
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Treatment Expectations and Impressions
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Questionnaires will be conducted to assess participants' treatment expectations and impressions.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Perceived Efficacy
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Questionnaires will be conducted to assess participants' impressions of perceived efficacy of the chosen topical cannabinoid.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Preference vs Other Analgesics
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Questionnaires will be conducted to assess participants' preference for the chosen topical cannabinoid vs other analgesics.
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Reported Adverse Effects
Time Frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Questionnaires will be conducted to assess participants' reported Adverse Effects
Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Half life analysis of cannabinoid and cannabinoid metabolites
Time Frame: baseline through 2 weeks
A total of six blood samples will be obtained and analyzed using population pharmacokinetic modeling with sparse sampling with cannabinoids and their kinetically distinct metabolites.
baseline through 2 weeks
Clearance analysis of cannabinoid and cannabinoid metabolites
Time Frame: baseline through 2 weeks
A total of six blood samples will be obtained and analyzed using population pharmacokinetic modeling with sparse sampling with cannabinoids and their kinetically distinct metabolites.
baseline through 2 weeks
Volume of distribution analysis of cannabinoid and cannabinoid metabolites
Time Frame: baseline through 2 weeks
A total of six blood samples will be obtained and analyzed using population pharmacokinetic modeling with sparse sampling with cannabinoids and their kinetically distinct metabolites.
baseline through 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Lindley, PhD, University of Colorado, Denver
  • Principal Investigator: Rachael Rzasa Lynn, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-1289
  • 25B2360 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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