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
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Condition or disease | Intervention/treatment | Phase |
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CBD Fear Inhibition | Drug: Cannabidiol Drug: Placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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
- 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.

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Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- right-handed
- between 21-50 years of age
- no current diagnosis of psychiatric or neurological conditions
- no history of heart disease or stroke
- generally healthy
- pass a screening test for the MR environment
Exclusion Criteria:
- contraindications to the MR environment
- use of psychotropic or neurological medication
- history of heart disease or stroke
- diabetes or other metabolic conditions
- self-reported high blood pressure
- history of concussions
- any diagnosed psychiatric or neurological condition
- have consumed alcohol in the 24-hour period prior to a scan
- consumed pain relievers in the 12-hours prior to a scan
- consumed food or drinks (except water) and/or nicotine/caffeine an hour prior to any scanning
- have used or take THC/CBD
- exercised within an hour of a scan

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
Contact: Jennifer L Robinson, Ph.D. | 3348444412 | jrobinson@auburn.edu | |
Contact: Ryan T Bird, M.S. | rtb0018@auburn.edu |
United States, Alabama | |
Auburn University MRI Research Center | Recruiting |
Auburn, Alabama, United States, 36849 | |
Contact: Julie Rodiek 334-844-7584 |
Principal Investigator: | Jennifer L Robinson, Ph.D. | Auburn University |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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