Pain Research: Innovative Strategies With Marijuana (PRISM)

U

University of Colorado Boulder (CU)

Status

Completed

Conditions

Chronic Low Back Pain
Cannabis Use
Chronic Pain

Treatments

Drug: Cannabis Edible

Study type

Observational

Funder types

Other

Identifiers

NCT03522324
R01AT009541

Details and patient eligibility

About

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.

Full 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.

Enrollment

268 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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