Pain Research: Innovative Strategies With Marijuana

  • STATUS
    Recruiting
  • days left to enroll
    62
  • participants needed
    283
  • sponsor
    University of Colorado, Boulder
Updated on 7 May 2021
pain relief
anxiety
chronic pain
moderate pain
back pain
tetrahydrocannabinol
anxiety/depression
cannabinoids
dronabinol
low back pain

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.

Details
Condition Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Chronic Pain, Chronic Pain, Post-Surgical Pain, Chronic Low Back Pain, Chronic Lower Back Pain, Cannabis Use, Pain (Pediatric), chronic pains
Treatment Cannabis Edible
Clinical Study IdentifierNCT03522324
SponsorUniversity of Colorado, Boulder
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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