Effects of Cannabidiol (CBD) on the Brain

Sponsor
Auburn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04831294
Collaborator
Folium Biosciences (Other), FutureCeuticals (Other)
15
1
2
17.5
0.9

Study Details

Study Description

Brief Summary

Cannabidiol (CBD) is a phytocannabinoid that is one of 113 identified cannabinoids in the cannabis plant. It is derived from the hemp plant, and may treat conditions like pain, insomnia, and anxiety. CBD is a critical component of medical marijuana and does not cause the "high" typically associated with cannabis. According to the World Health Organization, CBD has shown no evidence of abuse or dependence potential. However, to the investigator's knowledge, there have not been many acute clinical studies to characterize the effects of CBD in the brain. Despite the rapid influx in CBD readily available to the public, very little is known about such effects. Some studies have shown alterations in resting state connectivity, while others have described changes in specific regions of the brain, or in networks associated with various cognitive functions. For example, CBD has been shown to increase fronto-striatal connectivity and reduce mediotemporal-prefrontal connectivity, suggesting that CBD may affect brain regions involved in salience processing. Unfortunately, few studies have examined CBD in isolation. Additionally, several studies have suggested that CBD may have a neuroprotective effect when it comes to individuals at high risk for psychiatric conditions. In this study, the investigators propose an acute administration, double-blind, placebo-controlled study in which 100% THC-free CBD will be compared to placebo (https://foliumbiosciences.com/). To the investigator's knowledge, the acute effects of this specific product have not been tested. Specifically, the investigators will examine: 1) the neurometabolic and neurophysiological effects of CBD compared to placebo and 2) the behavioral effects of CBD on measures of working memory and response inhibition. Participants will be recruited to take encapsulated, THC-free CBD provided by Folium Biosciences, in which they will have a pre- and post-ingestion scan. Each participant will have a 72-hour washout period after which they will be asked to come back for a placebo scan (however, the order will be counterbalanced so that equal numbers of participants will receive placebo/supplement and supplement/placebo). Individuals will be randomized into the supplementation group, as well as the order.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single-site, randomized, placebo-controlled, cross-over, within-subjects design. Study sessions are 72 hours apart. Visits included pre-post assessments following ingestion of either placebo or CBD.Single-site, randomized, placebo-controlled, cross-over, within-subjects design. Study sessions are 72 hours apart. Visits included pre-post assessments following ingestion of either placebo or CBD.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Investigators and participants are blind to material assignment.
Primary Purpose:
Basic Science
Official Title:
Effects of Cannabidiol (CBD) on the Brain
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Apr 15, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cannabidiol (CBD)

A tincture containing 125mg broad spectrum CBD oil (6.7%), 24mg sunflower lecithin (1.3%), 56mg peppermint oil (3.0%), and 1661mg hempseed oil (89.0%) will be administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.

Drug: Cannabidiol
Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
Other Names:
  • CBD
  • Drug: Placebo
    Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.

    Placebo Comparator: Placebo

    A tincture containing 149mg sunflower lecithin (8.0%), 56mg peppermint oil (3.0%), 1661mg hempseed oil (89.0%) will be administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.

    Drug: Cannabidiol
    Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
    Other Names:
  • CBD
  • Drug: Placebo
    Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.

    Outcome Measures

    Primary Outcome Measures

    1. Behavioral Measures - Change in Go/NoGo Reaction Time [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Response/reaction time for each stimuli will be recorded in ms using E-Prime. Reaction times will be calculated for correct and incorrect trials separately.

    2. Behavioral Measures - Change in N-back Reaction Time [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Response/reaction time for each stimuli will be recorded in ms using E-Prime. Reaction times will be calculated for correct and incorrect trials separately; and for each level of n-back, separately.

    3. Behavioral Measures - Change in Go/No-Go Accuracy [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Accuracy will be determined as the number of trials correct, and errors will be classified as errors of omission or commission.

    4. Behavioral Measures - Change in N-back Accuracy [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Accuracy will be determined as the number of trials correct.

    5. Change in Concentration of Neurometabolites [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Magnetic resonance spectroscopy (MRS) measurements pre/post ingestion. The following are measured: glutamate, glutamine, gamma-aminobutyric acid, N-acetylaspartate, choline, creatine, glutathione, myo-inositol, aspartate, taurine, and lactate. LCModel software performed automatic quantification of in vivo proton MR spectra by analyzing spectra as a linear combination of model spectra from sequence-specific simulations. Water-suppressed spectra were eddy current corrected and quantified using the unsuppressed water signal. Cramer-Rao lower bounds were used as a measure of fit with CRLB > 50% rejected from further analysis. Metabolite concentrations were CSF-corrected, and quantified (in ppm).

    6. Changes in Functional Connectivity [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Blood-oxygen-level-dependent signal changes will be collected via functional magnetic resonance imaging (fMRI). We will assess pre- and post-drug/placebo connectivity changes across the whole-brain using standard preprocessing procedure (fmriprep) and the 'conn' connectivity toolbox.

    7. Blood Oxygen Level Dependent (BOLD) Changes [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Functional magnetic resonance imaging blood-oxygen-level-dependent signal changes across tasks, and during resting state

    8. BOLD - Change in Threat Response to Subliminal Emotion Stimuli [Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)]

      Responses to emotional face stimuli will be measured as a function of blood-oxygen-level-dependent signal change during emotion versus neutral condition in predefined regions of interest including the amygdala, anterior cingulate cortex, and superior temporal sulcus.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. right-handed

    2. between 21-50 years of age

    3. no current diagnosis of psychiatric or neurological conditions

    4. no history of heart disease or stroke

    5. generally healthy

    6. pass a screening test for the MR environment

    Exclusion Criteria:
    1. contraindications to the MR environment

    2. use of psychotropic or neurological medication

    3. history of heart disease or stroke

    4. diabetes or other metabolic conditions

    5. self-reported high blood pressure

    6. history of concussions

    7. any diagnosed psychiatric or neurological condition

    8. have consumed alcohol in the 24-hour period prior to a scan

    9. consumed pain relievers in the 12-hours prior to a scan

    10. consumed food or drinks (except water) and/or nicotine/caffeine an hour prior to any scanning

    11. have used or take THC/CBD

    12. exercised within an hour of a scan

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auburn University MRI Research Center Auburn Alabama United States 36849

    Sponsors and Collaborators

    • Auburn University
    • Folium Biosciences
    • FutureCeuticals

    Investigators

    • Principal Investigator: Jennifer L Robinson, Ph.D., Auburn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jennifer L. Robinson, Ph.D., Professor, Auburn University
    ClinicalTrials.gov Identifier:
    NCT04831294
    Other Study ID Numbers:
    • 20-107 MR 2003
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jennifer L. Robinson, Ph.D., Professor, Auburn University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 24, 2021