Clinical trial NCT03522324: Pain Research: Innovative Strategies With Marijuana
Official title: An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Chronic Low Back Pain
Cannabis Use
Keywords: Cannabis
Pain
Cytokines
Inflammation
Cognition
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Colorado State University
First posted: 2018-05-11
Enrollment: 268
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Interference: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 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).
measure: Inflammation: Circulating Levels of Cytokines
timeFrame: 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).
measure: Flanker Inhibitory Control Attention task (FICA) & International Shopping List Task (ISLT)
timeFrame: 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).
measure: Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
timeFrame: 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 outcomes:
measure: Pain Intensity: Current, Average and Worst pain using NIH Pain intensity scale.
timeFrame: 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).
measure: Health & Wellbeing
timeFrame: 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).
measure: Pittsburgh Sleep Quality Assessment (PSQI)
timeFrame: 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).
measure: Motor function
timeFrame: 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).
measure: Depression and Mood
timeFrame: 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).
measure: Acute Cognitive impairment: Flanker Inhibitory Control Attention task (FICA) and International Shopping List Task (ISLT).
timeFrame: 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).
measure: Inflammation: Circulating Levels of Cytokines
timeFrame: 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).
measure: Patient Global Impression of Change: Global Impression of Change Scale (PGIC).
timeFrame: Change over six month study, including after 2 week primary exposure period.
Other outcomes:
measure: Exploratory: Daily Follow-up Messages
timeFrame: 2 weeks (daily)
measure: Exploratory: Monthly Follow-up Surveys
timeFrame: 6 months (monthly)
measure: Objective physical activity/exercise
timeFrame: 2 weeks
measure: Physical activity/exercise
timeFrame: 2 weeks
Locations:
city: Boulder
country: United States
facility: Center for Innovation and Creativity
state: Colorado
Study officials:
affiliation: Institute of Cognitive Science, University of Colorado, Boulder
name: Cinnamon Bidwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: