Our proposal objective is to evaluate if state-regulated topical CBD-based products relieve chronic musculoskeletal pain and/or absorb into the bloodstream.
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
OBSERVATIONAL
Enrollment
77
Change in in PROMIS Pain Interference Score from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Levels of plasma cannabinoid and cannabinoid metabolites
Four venous blood samples will be obtained at baseline, 4 hours, 24 hours, and 2 weeks after first use of the selected topical cannabinoid.
Time frame: Baseline to 2 weeks
Opioid and non-opioid pain medications use
Participant self-report of opioid and non-opioid analgesic use
Time frame: Daily through 2 weeks
Reported drug effects
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
Time frame: Baseline, 4 hours, 24 hours, 2 weeks, 2 months
Change in in PROMIS Pain Intensity Score from Baseline to 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).
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile from Baseline to 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.
Time frame: 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
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."
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Change Patient Specific Functional Scale from Baseline to 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.
Time frame: 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
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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Oral Symbol Digit Test from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Flanker Inhibitory Control and Attention Test from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Pattern Comparison Processing Speed Test from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in NIH Toolbox® Picture Vocabulary Test from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in Fine Motor Function from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Change in Gross Motor Function from Baseline to 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.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks
Abuse liability
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
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Treatment Expectations and Impressions
Questionnaires will be conducted to assess participants' treatment expectations and impressions.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Perceived Efficacy
Questionnaires will be conducted to assess participants' impressions of perceived efficacy of the chosen topical cannabinoid.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Preference vs Other Analgesics
Questionnaires will be conducted to assess participants' preference for the chosen topical cannabinoid vs other analgesics.
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Participant Reported Adverse Effects
Questionnaires will be conducted to assess participants' reported Adverse Effects
Time frame: Assessed at baseline, 4 hours, 24 hours, 2 weeks and 2 months
Half life analysis of cannabinoid and cannabinoid metabolites
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.
Time frame: baseline through 2 weeks
Clearance analysis of cannabinoid and cannabinoid metabolites
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.
Time frame: baseline through 2 weeks
Volume of distribution analysis of cannabinoid and cannabinoid metabolites
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.
Time frame: baseline through 2 weeks