Pain Research: Innovative Strategies With Marijuana

Chronic Pain Clinical Trial

— PRISM  

Official title:

An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522324
• Other study ID #: R01AT009541
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: October 12, 2023

Study information

• Verified date: October 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study tests the effects of cannabinoid levels in blood on pain relief, inflammation, and cognitive dysfunction in chronic pain patients who choose to use edible cannabis. Over a two-week period, participants use an edible product of their choice. Blood levels of 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) will be measured before, during, and after the two-week exposure period to determine whether there are associations with pain, inflammation, sleep, physical activity, anxiety/depression, and cognitive dysfunction. After the two-week self-administration period, participants will be followed for six months to collect self-report data on cannabis use, pain levels, sleep quality, and mental health symptoms.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: October 12, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cannabis Use
• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain
• Marijuana Abuse

Intervention

Drug:
• Cannabis Edible
Self-Directed Use (ad-libitum)

Locations

Country	Name	City	State
United States	Center for Innovation and Creativity	Boulder	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Colorado State University, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Daily Follow-up Messages	Brief self-report from participants on cannabis use, pain, and sleep in the past 24 hours.	2 weeks (daily)
Other	Exploratory: Monthly Follow-up Surveys	Self-report from participants on all drug use, subjective cognitive function, pain, sleep, and mental health	6 months (monthly)
Other	Objective physical activity/exercise	Physical activity and sleep via objective daily data on wearable watch.	2 weeks
Other	Physical activity/exercise	Physical activity via subjective self-report data	2 weeks
Primary	Pain Interference: Roland Morris Disability Questionnaire (RMDQ)	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.	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).
Primary	Inflammation: Circulating Levels of Cytokines	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).
Primary	Flanker Inhibitory Control Attention task (FICA) & International Shopping List Task (ISLT)	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).
Primary	Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)	Subjective report of 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).
Secondary	Pain Intensity: Current, Average and Worst pain using NIH Pain intensity scale.	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).
Secondary	Health & Wellbeing	Self-report measure across primary domains of health-related well-being (e.g. exercise and diet).	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).
Secondary	Pittsburgh Sleep Quality Assessment (PSQI)	Self-report assessment of sleep quality.	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).
Secondary	Motor function	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.	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).
Secondary	Depression and Mood	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.	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).
Secondary	Acute Cognitive impairment: Flanker Inhibitory Control Attention task (FICA) and International Shopping List Task (ISLT).	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).
Secondary	Inflammation: Circulating Levels of Cytokines	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.	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).
Secondary	Patient Global Impression of Change: Global Impression of Change Scale (PGIC).	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.	Change over six month study, including after 2 week primary exposure period.

External Links

•   CUChange Lab, University of Colorado, Boulder