- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522103
Cannabis Observational Study on Mood, Inflammation, and Cognition (COSMIC)
Marijuana Harm Reduction: Innovative Strategies for Developing New Knowledge
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Cannabinoid Concentration
Time Frame: 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).
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To test the hypothesis that a high delta-9-tetrahydrocannabinol (THC) strain of marijuana will be associated with greater blood levels of THC and greater harmful effects, we will measure the concentrations of the cannabinoid THC in blood (ng/ml).
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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).
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Change in Inflammation: Circulating Levels of cytokines (panel of inflammatory markers)
Time Frame: 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).
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Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels.
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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).
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The Drug Effects Questionnaire (DEQ)
Time Frame: 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).
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The DEQ is a 5 items visual analog scale used to measure the strength of marijuana as well as the desirable effects (de Wit & Phillips, 2012).
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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).
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The Addiction Research Center Inventory (ARCI)
Time Frame: 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).
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The ARCI (Martin, Sloan, Sapira, & Jasinski, 1971), including the ARCI-Marijuana (M) scale (Chait, Fischman, & Schuster, 1985) will be used to measure subjective effects of marijuana in addition to drug-induced euphoria, stimulant-like effects, intellectual efficiency and energy, sedation, dysphoria, and other somatic effects.
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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).
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Profile of Mood States (POMS)
Time Frame: 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).
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The Profile of Mood States (POMS) will be used to collect baseline information on mood as well as information on mood changes throughout the study.
(Johanson & Uhlenhuth, 1980; McNair, Lorr, & Droppleman, 1971)
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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).
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Cognitive Impairment
Time Frame: 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).
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Co-outcomes testing multiple domains of thinking, memory, and perception (NIH Toolbox), including the Flanker Inhibitory Control and Attention Task, Pattern Comparison Processing Speed Test, the Picture Sequence Memory Test, the List Sorting Working Memory Test, and immediate and delayed recall via the International Shopping List Test (ISLT).
Cognitive outcomes are measured in standard scores (e.g.
Range of >70 to >140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a standard score of overall cognitive function.
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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).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kent Hutchison, PhD, University of Colorado, Denver
Publications and helpful links
General Publications
- 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. 2022 Nov 15. doi: 10.1089/can.2022.0020. Online ahead of print.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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