Pain Research: Innovative Strategies With Marijuana



Status:Recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Chronic Pain, Psychiatric
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:21 - 70
Updated:12/1/2018
Start Date:June 1, 2018
End Date:March 31, 2022
Contact:Leah Hitchcock, PhD
Email:prism.custudy@gmail.com
Phone:303-492-0288

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

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.

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.

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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