Clinical trial NCT04831294: Effects of Cannabidiol (CBD) on the Brain
Official title: Effects of Cannabidiol (CBD) on the Brain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: CBD
Fear
Inhibition
Keywords: cannabidiol
placebo
rct
clinical trial
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Folium Biosciences
name: FutureCeuticals
First posted: 2021-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Behavioral Measures - Change in Go/NoGo Reaction Time
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in N-back Reaction Time
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in Go/No-Go Accuracy
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Behavioral Measures - Change in N-back Accuracy
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Change in Concentration of Neurometabolites
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Changes in Functional Connectivity
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: Blood Oxygen Level Dependent (BOLD) Changes
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
measure: BOLD - Change in Threat Response to Subliminal Emotion Stimuli
timeFrame: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University MRI Research Center
state: Alabama
Study officials:
affiliation: Auburn University
name: Jennifer L Robinson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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