Clinical trial NCT03522103: Cannabis Observational Study on Mood, Inflammation, and Cognition
Official title: Marijuana Harm Reduction: Innovative Strategies for Developing New Knowledge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Inflammatory Response
Mood
Cognitive Change
Keywords: Cannabis
Marijuana
Cognition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2018-05-11
Enrollment: 421
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: This project examines the effects of cannabis on cognition and other domains of function and whether those effects are dependent upon the ratio of THC to CBD in the product. Current cannabis users are asked to stop using their typical product and to use cannabis containing different ratios of the cannabinoids THC and CBD. Participants complete baseline assessments including cognitive tasks, clinical measures, substance use history, and blood draw. Participants then acquire and use their study strain on their own, and after a period of use the mobile pharmacology laboratory goes to a location of their choosing. They complete cognitive, motor and blood-based assessments, then leave the mobile lab to use their study product one last time, returning to the mobile lab to complete cognitive, motor, and blood-based assessments immediately after use and one hour after use. A small subset of participants complete all of these procedures but use edible as opposed to flower-based products.

Detailed description: Cannabis research can be dated back to the 1970's where standardized smoking of low potency cannabis in a laboratory setting has been the primary method used to understand the effects of the drug. The objective of this program is to use a naturalistic design to advance a more nuanced understanding of the potential outcomes associated with using different strains of marijuana. Researchers need to understand the effects of commonly used cannabis strains, as they are used in every day life. Commonly available strains of cannabis sold in dispensaries in Colorado have 3-5 times greater potency of cannabinoids, such as the psychoactive compound tetrahydrocannabinol (THC), than what has been used in laboratory settings. It is possible that laboratory based studies underestimate the effects of more potent strains that are widely available. Also, scientists have focused on the effects of THC while mostly ignoring other major cannabinoids (e.g. cannabidiol or CBD) and their synergistic relationship.

The objective of this study is to observe how different strains of marijuana, based off their unique cannabinoid content, can influence your mental and physical state in real time. This program will allow researchers to observe these effects immediately before and after cannabis use. A participant will use cannabis in the comfort of their home, and will walk out their front door and into a mobile lab that will be parked outside of their house. In this study, there is no need to smoke and drive.

Participation is this study involves one appointment at the laboratory facility in Boulder and one appointment in the mobile laboratory.

Eligibility criteria: Inclusion Criteria:

* Have prior experience with edibles
* Have used marijuana in the past month. This includes any form of marijuana consumption including flower, oil, wax, tinctures and edibles
* Not using other drugs (cocaine, opiates, methamphetamine) in the past 60 days
* Light alcohol use

Exclusion Criteria:

* Currently using a strain with greater than 1% CBD or less than 18% THC
* A University of Colorado student or employee
* Heavy tobacco use
* Are currently pregnant
* In treatment for psychotic disorder, bipolar disorder or schizophrenia

Primary outcomes:
measure: Blood Cannabinoid Concentration
timeFrame: Change over 3 time points over 5 days: Baseline (before 5 days of use), Pre-Administration (after 5 days of use but prior to acute use), and Post-Administration (after 5 days of use but 60 minutes after acute use).
measure: Change in Inflammation: Circulating Levels of cytokines (panel of inflammatory markers)
timeFrame: Change over 3 time points over 5 days: Baseline (before 5 days of use), Pre-Administration (after 5 days of use but prior to acute use), and Post-Administration (after 5 days of use but 60 minutes after acute use).
measure: The Drug Effects Questionnaire (DEQ)
timeFrame: Change over 2 time points over 1 hour: Pre-Administration (after 5 days of use but prior to acute self-administration), and Post-Administration (after 5 days of use but 60 minutes after acute self-administration).
measure: The Addiction Research Center Inventory (ARCI)
timeFrame: Change over 2 time points over 1 hour: Pre-Administration (after 5 days of use but prior to acute self-administration), and Post-Administration (after 5 days of use but 60 minutes after acute self-administration).
measure: Profile of Mood States (POMS)
timeFrame: Change over 3 time points over 5 days: Baseline (before 5 days of use), Pre-Administration (after 5 days of use but prior to acute use), and Post-Administration (after 5 days of use but 60 minutes after acute use).
measure: Cognitive Impairment
timeFrame: Change over 3 time points over 5 days: Baseline (before 5 days of use), Pre-Administration (after 5 days of use but prior to acute use), and Post-Administration (after 5 days of use but 60 minutes after acute use).
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kent Hutchison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibson LP, Mueller RL, Winiger EA, Klawitter J, Sempio C, Williams S, Bryan AD, Bidwell LC, Hutchison KE. Cannabinoid Exposure and Subjective Effects of THC and CBD in Edible Cannabis Products. Cannabis Cannabinoid Res. 2024 Feb;9(1):320-334. doi: 10.1089/can.2022.0020. Epub 2022 Nov 15.
citation: Karoly HC, Milburn MA, Brooks-Russell A, Brown M, Streufert J, Bryan AD, Lovrich NP, DeJong W, Cinnamon Bidwell L. Effects of High-Potency Cannabis on Psychomotor Performance in Frequent Cannabis Users. Cannabis Cannabinoid Res. 2022 Feb;7(1):107-115. doi: 10.1089/can.2020.0048. Epub 2020 Sep 10.