Pain Research: Innovative Strategies With Marijuana (PRISM)
An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The National Center for Health Statistics reports that approximately 76 million Americans suffer from chronic pain, affecting the lives of more Americans than cancer, diabetes, and heart disease combined. Perhaps because of its ubiquity and the challenge to its treatment, relief from chronic pain is by far the most commonly cited condition by patients for use of marijuana, with 87%-94% of medical marijuana users reporting using for relief of a pain condition.
Although the mechanisms are still unclear, marijuana and its constituent cannabinoids, including 9-delta-tetrahydrocannabinol (THC), are thought to be involved in reducing pain and associated inflammation. However, THC is also associated with harm in the form of cognitive dysfunction. Synergistic interactions of multiple cannabinoids are believed to produce different effects on both pain relief and cognitive function as compared to THC alone. For example, cannabidiol (CBD) is another primary cannabinoid that may work synergistically with THC in a multi-target analgesic approach.
This study examines the effects of cannabinoids in edible form on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use marijuana in the context of a short-term (2 weeks), patient-oriented, observational design and a mobile pharmacology and phlebotomy lab.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Boulder, Colorado, United States, 80304
- Center for Innovation and Creativity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Intent to initiate use of marijuana to treat chronic pain
- At least one episode of lifetime marijuana use, but infrequent marijuana use for prior six months
- Self-reported non-specific chronic low back pain for at least three months
- Health eligibility approved by study physician
- At least mild to moderate pain intensity OR pain interferes with important life functions
Exclusion Criteria:
- Other drug use (cocaine, methamphetamine, etc.) in the past 3 days and/or actively seeking or in treatment for any substance use disorder
- Use of marijuana to treat pain at any time in lives
- Current use of psychotropic medications (other than SSRIs and ADHD meds), or use of antivirals, steroids, or regular use of maximal doses of NSAIDS
- A daily tobacco user
- Are currently pregnant or trying to become pregnant
- Acute illness (other than chronic pain) or any immune-related disease (e.g., HIV)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
Time Frame: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).
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The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain.
Scores range from 0 to 24, with higher scores indicating more pain interference.
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Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).
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Inflammation: Circulating Levels of Cytokines
Time Frame: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).
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Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use.
Higher numbers indicate higher levels of circulating pro-inflammatory cytokines.
Results are in pg/mL and are separated by the three cytokines: IL-1b, IL-6, and IL-10.
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Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).
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Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)
Time Frame: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
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Co-outcomes testing cognitive impairment in the domains of immediate and delayed recall (ISLT) and attention and inhibitory control (FICA).
Cognitive outcomes are measured in standard scores (e.g.
Range of >70 to >140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.
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Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
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Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Time Frame: Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
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Subjective report of cognitive function using the Perceived Cognitive Impairments subscale of the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog).
Possible scores range from 0-80 where higher scores are associated with higher levels of perceived impairment.
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Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity: Current Pain Using NIH Pain Intensity Scale.
Time Frame: Change over 2 weeks
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Test effects of cannabinoids on pain using the NIH Pain intensity scale for "current pain" (on a scale from 0-10 with 10 being the worst).
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Change over 2 weeks
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Health & Wellbeing
Time Frame: Change over 2 weeks
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Self-report measure across primary domains of diet, assessment of sleep quality, and health-related well-being. Each domain was assessed with the following single items: Diet: "In general, how healthy is your overall diet? Would you say" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor) Sleep Quality: "During the past 2 weeks, how would you rate your sleep quality overall?" (response options 0- very good; 1- fairly good; 2- fairly bad; 3- very bad") Health Related Wellbeing: "In general, how would you describe your health?" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor) |
Change over 2 weeks
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Pittsburgh Sleep Quality Assessment (PSQI)
Time Frame: Change over 4 weeks
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The Pittsburgh Sleep Quality Assessment (PSQI) is a self-report assessment of sleep quality.9
self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances (Scores range from 0 to 21 overall, with scores greater than 5 suggesting significant sleep difficulties).
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Change over 4 weeks
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Motor Function
Time Frame: Change over 2 weeks
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Motor control assessed via dynamic sway and proprioception.
Motor outcomes were aggregated to reflect a Z-score of overall motor function.
Scores reported below are sum of Motor Battery Balance z-scores (Eyes Open, Eyes Closed, and Head Back).
Higher scores correspond to worse balance- there is not a maximum score.
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Change over 2 weeks
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Depression and Stress
Time Frame: Change over 2 weeks
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The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. For this aim, the Depression and Stress subscales were used. Depression subscale score range 0-21 Normal (0 to 4), Mild (5 to 6), Moderate, (7 to 10), Severe (11 to 13), Extremely Severe (14 and above) Stress subscale score range 0-33 Normal (0 to 14), Mild (15 to 18), Moderate, (19 to 25), Severe (26 to 33) |
Change over 2 weeks
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Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT).
Time Frame: 2 Weeks
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Co-outcomes testing cognitive impairment after acute use of cannabis in the domains of immediate and delayed recall (ISLT) and and attention and inhibitory control (FICA).
Cognitive outcomes are measured in standard scores (e.g.
Range of <70 to >140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function.
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2 Weeks
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Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
Time Frame: Change over 2 week primary exposure period.
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Patient Global Impression of Change Scale (PGIC) measures self-reported change on a 1-7 scale (i.e. from 1 (very much worse) to 7 (very much improved) in pain.
Changes in this measure will be tested in relation to THC and CBD blood levels.
Scale possible score range 1-7, with higher scores indicating the largest amount of possible change.
Importantly, it is a subjective self-assessment of change and is only measured at the 2 week timepoint.
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Change over 2 week primary exposure period.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Exploratory: Daily Follow-up Messages
Time Frame: 2 weeks (daily)
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Brief self-report from participants on pain and sleep in the past 24 hours.
These are 1-item novel questions in a daily, text based survey.
Pain and sleep are on a scale of 1-10, with higher numbers being more pain or better sleep.
Score is an average rating over 14 days.
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2 weeks (daily)
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Exploratory: Monthly Follow-up Surveys
Time Frame: 6 months (monthly)
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Self-report from participants on pain levels (0-10 with 10 being worst pain), sleep quality (0-10 with 10 being best sleep), perceived cognitive ability (0 - 27 with 27 being the best), perceived cognitive impairments (0-72 with 72 being the worst), and general health (0-4 with 4 being best).
Scores are reported as average scores reported once a month over six months.
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6 months (monthly)
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Objective Physical Activity/Exercise
Time Frame: 2 weeks
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Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).
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2 weeks
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Physical Activity/Exercise
Time Frame: 2 weeks
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Physical activity via subjective self-report data using the Stanford Leisure-Time Activity Categorical item with 6 item responses (L-CAT; 1-6).
Scores are reported as a mean between 1 and 6, larger numbers correspond to higher levels of activity.
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2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cinnamon Bidwell, PhD, Institute of Cognitive Science, University of Colorado, Boulder
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT009541 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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