Pain Research: Innovative Strategies With Marijuana

Completed

Conditions: Chronic Low Back Pain
Cannabis Use
Chronic Pain

Registration Number: NCT03522324

Lead Sponsor: University of Colorado, Boulder

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 268

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Interference: Roland Morris Disability Questionnaire (RMDQ)	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).	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.
Inflammation: Circulating Levels of Cytokines	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).	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.
Flanker Inhibitory Control Attention Task (FICA) & International Shopping List Task (ISLT)	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.
Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)	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).	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.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity: Current Pain Using NIH Pain Intensity Scale.	Change over 2 weeks	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).
Health & Wellbeing	Change over 2 weeks	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)
Pittsburgh Sleep Quality Assessment (PSQI)	Change over 4 weeks	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).
Motor Function	Change over 2 weeks	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.
Depression and Stress	Change over 2 weeks	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)
Acute Cognitive Impairment: Flanker Inhibitory Control Attention Task (FICA) and International Shopping List Task (ISLT).	2 Weeks	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.
Patient Global Impression of Change: Global Impression of Change Scale (PGIC).	Change over 2 week primary exposure period.	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.

Trial Locations

Locations (1): Center for Innovation and Creativity
🇺🇸
Boulder, Colorado, United States
Center for Innovation and Creativity
🇺🇸Boulder, Colorado, United States