CBD on Brain Function (CBD Trial)

Palo Alto (17 mi)

Overseen byJennifer L Robinson, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Auburn University

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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

This trial is for right-handed adults aged 21-50 who are generally healthy, with no psychiatric or neurological conditions, heart disease, stroke history, or contraindications to MRI scans. Participants must not consume certain substances before scans and cannot be on psychotropic or neurological medications.

Treatment Details

The study tests the effects of THC-free Cannabidiol (CBD) versus a placebo on brain function and behavior. It's a double-blind study where participants take CBD capsules and undergo pre- and post-ingestion brain scans in two sessions separated by a washout period.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cannabidiol (CBD)Experimental Treatment2 Interventions

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.

Group II: PlaceboPlacebo Group2 Interventions

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.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Epidiolex for: