- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522324
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 Contact
- Name: Leah Hitchcock, PhD
- Phone Number: 303-492-0288
- Email: prism.custudy@gmail.com
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 |
---|---|---|
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).
|
Measure of pain interference (RMDQ), using the total RMDQ score (0-24).
THC and CBD blood levels will be tested in relation to all outcomes.
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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).
|
Inflammation: Circulating Levels of Cytokines
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).
|
Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use.
THC and CBD blood levels will be tested in relation to all outcomes.
|
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).
|
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).
|
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.
|
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
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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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity: Current, Average and Worst pain using NIH Pain intensity scale.
Time Frame: Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
|
Test effects of cannabinoids on pain using the "current pain", "average pain", and "worst pain" versions of the Pain Intensity scale (on a scale from 0-10).
THC and CBD blood levels will be tested in relation to all outcomes.
|
Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
|
Health & Wellbeing
Time Frame: Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
|
Self-report measure across primary domains of health-related well-being (e.g.
exercise and diet).
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Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
|
Pittsburgh Sleep Quality Assessment (PSQI)
Time Frame: Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Self-report assessment of sleep quality.
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Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Motor function
Time Frame: Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Physical function assessment of motor flexibility and control.
Motor outcomes can be aggregated via Z-score to reflect a Z-score of overall motor function.
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Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Depression and Mood
Time Frame: Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Self-report measures of depression, anxiety, and stress.
Given the observational nature of the study, co-outcomes are appropriate to comprehensively assess change in depression/negative affect over the course of the study.
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Change over four time points over 2 weeks: Baseline (before start of edible use), Pre-Administration (after 2 weeks of edible use and post-acute administration), and Post-Administration (1 and 2 hours post-use. acute measure of edible cannabis effects).
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Acute Cognitive impairment: Flanker Inhibitory Control Attention task (FICA) and International Shopping List Task (ISLT).
Time Frame: Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).
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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.
|
Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).
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Inflammation: Circulating Levels of Cytokines
Time Frame: Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).
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Acute changes in inflammation (panel of inflammatory markers) immediately before and after cannabis use.
THC and CBD blood levels will be tested in relation to all outcomes.
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Acute changes in three time points over 2 hours: Pre-Administration (after 2 weeks of use, before acute administration), Post-Administration 1-hr & 2-hr (after 2 weeks of use, 1 and 2 hours after acute administration).
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Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
Time Frame: Change over six month study, including after 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 anxiety.
Changes in this measure will be tested in relation to THC and CBD blood levels.
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Change over six month study, including after 2 week primary exposure period.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory: Daily Follow-up Messages
Time Frame: 2 weeks (daily)
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Brief self-report from participants on cannabis use, pain, and sleep in the past 24 hours.
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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 all drug use, subjective cognitive function, pain, sleep, and mental health
|
6 months (monthly)
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Objective physical activity/exercise
Time Frame: 2 weeks
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Physical activity and sleep via objective daily data on wearable watch.
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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
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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 (Actual)
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
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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