Cannabis Observational Study on Mood, Inflammation, and Cognition

NCT03522103 | Completed

• 1 other identifier: 20-2547
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Inflammatory Response; Mood; Cognitive Change

Keywords

Cannabis; Marijuana; Cognition

Outcome Measures

Primary Outcomes (6)

• 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).

  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: 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.

  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 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).

  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 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.

  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).

• 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)

  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).

• 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.

  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).

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• 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.

  PMID: 38608236 DERIVED

• 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.

  PMID: 36378267 DERIVED

• 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.

  PMID: 33998859 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (including DNA analysis) and gut microbiome samples (including microbial DNA analysis)

MeSH Terms

Conditions

Inflammation; Marijuana Abuse

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kent Hutchison, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: July 1, 2016
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)