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InflammationCOSMICNCT03522103

Cannabis Observational Study on Mood, Inflammation, and Cognition

An observational study of Inflammation and Inflammatory Response, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Inflammation, Inflammatory Response, Mood
How many people
421 participants
Where
1 siteUnited States
Study dates
1 Jul 2016to 15 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community Sample

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Denver

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Marijuana Harm Reduction: Innovative Strategies for Developing New Knowledge

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.

Read the 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.

Keywords
Cannabis, Marijuana, Cognition
Medical subject headings
Inflammation, Marijuana Abuse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Cannabinoid Concentration

    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).

    Measured: 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).

  2. Change in Inflammation: Circulating Levels of cytokines (panel of inflammatory markers)

    Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels.

    Measured: 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).

  3. The Drug Effects Questionnaire (DEQ)

    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).

    Measured: 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).

  4. The Addiction Research Center Inventory (ARCI)

    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.

    Measured: 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).

  5. Profile of Mood States (POMS)

    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)

    Measured: 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).

  6. Cognitive Impairment

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start1 Jul 2016
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522103
Sponsor's protocol ID
20-2547
Acronym
COSMIC
Status last verified
Jul 2021
First submitted
30 Apr 2018
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen MY, Kramer EB, Gibson LP, Bidwell LC, Hutchison KE, Bryan AD. Investigating the Relationship Between Cannabis Expectancies and Anxiety, Depression, and Pain Responses After Acute Flower and Edible Cannabis Use. Cannabis Cannabinoid Res. 2025 Feb;10(1):71-80. doi: 10.1089/can.2023.0264. Epub 2024 Apr 12.

    PubMed 38608236

  • 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.

    PubMed 36378267

  • 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.

    PubMed 33998859

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation and Inflammatory Response, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03522103, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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