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Effects of Cannabidiol (CBD) on the Brain (CBD)

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ClinicalTrials.gov Identifier: NCT04831294
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborators:
Folium Biosciences
FutureCeuticals
Information provided by (Responsible Party):
Jennifer L. Robinson, Ph.D., Auburn University

Study Description
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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
CBD Fear Inhibition Drug: Cannabidiol Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : July 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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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 Name: 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 Name: CBD

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


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral Measures - Change in Go/NoGo Reaction Time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

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): NCT04831294


Contacts
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Contact: Jennifer L Robinson, Ph.D. 3348444412 jrobinson@auburn.edu
Contact: Ryan T Bird, M.S. rtb0018@auburn.edu

Locations
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United States, Alabama
Auburn University MRI Research Center Recruiting
Auburn, Alabama, United States, 36849
Contact: Julie Rodiek    334-844-7584      
Sponsors and Collaborators
Auburn University
Folium Biosciences
FutureCeuticals
Investigators
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Principal Investigator: Jennifer L Robinson, Ph.D. Auburn University
More Information
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Publications:

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Responsible Party: Jennifer L. Robinson, Ph.D., Professor, Auburn University
ClinicalTrials.gov Identifier: NCT04831294    
Other Study ID Numbers: 20-107 MR 2003
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Our consent form does include an optional item for participants to indicate whether or not they would be agreeable to their data being shared.

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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., Auburn University:
cannabidiol
placebo
rct
clinical trial
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants