Cannabis Observational Study on Mood, Inflammation, and Cognition (COSMIC)

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Inflammation
Cognitive Change
Inflammatory Response
Mood

Study type

Observational

Funder types

Other

Identifiers

NCT03522103
20-2547

Details and patient eligibility

About

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.

Full 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.

Enrollment

421 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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