Cannabis Observational Study on Mood, Inflammation, and Cognition (COSMIC)
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| ClinicalTrials.gov Identifier: NCT03522103 |
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Recruitment Status :
Completed
First Posted : May 11, 2018
Last Update Posted : July 12, 2021
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| Condition or disease |
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| Inflammation Inflammatory Response Mood Cognitive Change |
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 : | Observational |
| Actual Enrollment : | 421 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Marijuana Harm Reduction: Innovative Strategies for Developing New Knowledge |
| Actual Study Start Date : | July 1, 2016 |
| Actual Primary Completion Date : | December 15, 2020 |
| Actual Study Completion Date : | December 15, 2020 |
- 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). ]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).
- 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). ]Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels.
- 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). ]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).
- 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). ]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.
- 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). ]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)
- 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). ]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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522103
| United States, Colorado | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | Kent Hutchison, PhD | University of Colorado, Denver |
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT03522103 |
| Other Study ID Numbers: |
20-2547 |
| First Posted: | May 11, 2018 Key Record Dates |
| Last Update Posted: | July 12, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cannabis Marijuana Cognition |
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Inflammation Pathologic Processes |