CBDCBDNCT04831294
Effects of Cannabidiol (CBD) on the Brain
A study testing Cannabidiol in people with CBD and Fear, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- CBD, Fear, Inhibition
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Auburn University MRI Research Center
Auburn, Alabama, 36849
About this study
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.
- Conditions
- CBD, Fear, Inhibition
- Being tested
- Cannabidiol, Placebo
- Keywords
- cannabidiol, placebo, rct, clinical trial
- Medical subject headings
- Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
PlaceboDrug
Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | 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. Receives: Drug: Cannabidiol; Drug: Placebo |
| Placebo | Placebo comparator | 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. Receives: Drug: Cannabidiol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Measures - Change in Go/NoGo Reaction Time
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.
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Behavioral Measures - Change in N-back Reaction Time
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.
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Behavioral Measures - Change in Go/No-Go Accuracy
Accuracy will be determined as the number of trials correct, and errors will be classified as errors of omission or commission.
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Behavioral Measures - Change in N-back Accuracy
Accuracy will be determined as the number of trials correct.
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Change in Concentration of Neurometabolites
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).
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Changes in Functional Connectivity
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.
Measured: 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 (BOLD) Changes
Functional magnetic resonance imaging blood-oxygen-level-dependent signal changes across tasks, and during resting state
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
BOLD - Change in Threat Response to Subliminal Emotion Stimuli
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.
Measured: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start15 Jul 2021
- Primary completion15 May 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for CBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Folium Biosciences, FutureCeuticals
- Responsible party
- Principal investigator, Jennifer L. Robinson, Ph.D., Auburn University
- Investigators
- Jennifer L Robinson, Ph.D., Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831294
- Sponsor's protocol ID
- 20-107 MR 2003
- Acronym
- CBD
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our consent form does include an optional item for participants to indicate whether or not they would be agreeable to their data being shared.
Publications
Grimm O, Loffler M, Kamping S, Hartmann A, Rohleder C, Leweke M, Flor H. Probing the endocannabinoid system in healthy volunteers: Cannabidiol alters fronto-striatal resting-state connectivity. Eur Neuropsychopharmacol. 2018 Jul;28(7):841-849. doi: 10.1016/j.euroneuro.2018.04.004. Epub 2018 Jun 7.
PubMed 29887287Wall MB, Pope R, Freeman TP, Kowalczyk OS, Demetriou L, Mokrysz C, Hindocha C, Lawn W, Bloomfield MA, Freeman AM, Feilding A, Nutt D, Curran HV. Dissociable effects of cannabis with and without cannabidiol on the human brain's resting-state functional connectivity. J Psychopharmacol. 2019 Jul;33(7):822-830. doi: 10.1177/0269881119841568. Epub 2019 Apr 23.
PubMed 31013455Beale C, Broyd SJ, Chye Y, Suo C, Schira M, Galettis P, Martin JH, Yucel M, Solowij N. Prolonged Cannabidiol Treatment Effects on Hippocampal Subfield Volumes in Current Cannabis Users. Cannabis Cannabinoid Res. 2018 Apr 1;3(1):94-107. doi: 10.1089/can.2017.0047. eCollection 2018.
PubMed 29682609Wilson R, Bossong MG, Appiah-Kusi E, Petros N, Brammer M, Perez J, Allen P, McGuire P, Bhattacharyya S. Cannabidiol attenuates insular dysfunction during motivational salience processing in subjects at clinical high risk for psychosis. Transl Psychiatry. 2019 Aug 22;9(1):203. doi: 10.1038/s41398-019-0534-2.
PubMed 31439831O'Neill A, Wilson R, Blest-Hopley G, Annibale L, Colizzi M, Brammer M, Giampietro V, Bhattacharyya S. Normalization of mediotemporal and prefrontal activity, and mediotemporal-striatal connectivity, may underlie antipsychotic effects of cannabidiol in psychosis. Psychol Med. 2021 Mar;51(4):596-606. doi: 10.1017/S0033291719003519. Epub 2020 Jan 29.
PubMed 31994476Bhattacharyya S, Falkenberg I, Martin-Santos R, Atakan Z, Crippa JA, Giampietro V, Brammer M, McGuire P. Cannabinoid modulation of functional connectivity within regions processing attentional salience. Neuropsychopharmacology. 2015 May;40(6):1343-52. doi: 10.1038/npp.2014.258. Epub 2014 Sep 23.
PubMed 25249057Borgwardt SJ, Allen P, Bhattacharyya S, Fusar-Poli P, Crippa JA, Seal ML, Fraccaro V, Atakan Z, Martin-Santos R, O'Carroll C, Rubia K, McGuire PK. Neural basis of Delta-9-tetrahydrocannabinol and cannabidiol: effects during response inhibition. Biol Psychiatry. 2008 Dec 1;64(11):966-73. doi: 10.1016/j.biopsych.2008.05.011. Epub 2008 Jun 27.
PubMed 18589404Allendorfer JB, Nenert R, Bebin EM, Gaston TE, Grayson LE, Hernando KA, Houston JT, Hansen B, Szaflarski JP. fMRI study of cannabidiol-induced changes in attention control in treatment-resistant epilepsy. Epilepsy Behav. 2019 Jul;96:114-121. doi: 10.1016/j.yebeh.2019.04.008. Epub 2019 May 24.
PubMed 31129526Bhattacharyya S, Wilson R, Appiah-Kusi E, O'Neill A, Brammer M, Perez J, Murray R, Allen P, Bossong MG, McGuire P. Effect of Cannabidiol on Medial Temporal, Midbrain, and Striatal Dysfunction in People at Clinical High Risk of Psychosis: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1107-1117. doi: 10.1001/jamapsychiatry.2018.2309.
PubMed 30167644Pretzsch CM, Voinescu B, Mendez MA, Wichers R, Ajram L, Ivin G, Heasman M, Williams S, Murphy DG, Daly E, McAlonan GM. The effect of cannabidiol (CBD) on low-frequency activity and functional connectivity in the brain of adults with and without autism spectrum disorder (ASD). J Psychopharmacol. 2019 Sep;33(9):1141-1148. doi: 10.1177/0269881119858306. Epub 2019 Jun 25.
PubMed 31237191Hermann D, Sartorius A, Welzel H, Walter S, Skopp G, Ende G, Mann K. Dorsolateral prefrontal cortex N-acetylaspartate/total creatine (NAA/tCr) loss in male recreational cannabis users. Biol Psychiatry. 2007 Jun 1;61(11):1281-9. doi: 10.1016/j.biopsych.2006.08.027. Epub 2007 Jan 17.
PubMed 17239356Fusar-Poli P, Crippa JA, Bhattacharyya S, Borgwardt SJ, Allen P, Martin-Santos R, Seal M, Surguladze SA, O'Carrol C, Atakan Z, Zuardi AW, McGuire PK. Distinct effects of delta9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing. Arch Gen Psychiatry. 2009 Jan;66(1):95-105. doi: 10.1001/archgenpsychiatry.2008.519.
PubMed 19124693Bhattacharyya S, Morrison PD, Fusar-Poli P, Martin-Santos R, Borgwardt S, Winton-Brown T, Nosarti C, O' Carroll CM, Seal M, Allen P, Mehta MA, Stone JM, Tunstall N, Giampietro V, Kapur S, Murray RM, Zuardi AW, Crippa JA, Atakan Z, McGuire PK. Opposite effects of delta-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology. Neuropsychopharmacology. 2010 Feb;35(3):764-74. doi: 10.1038/npp.2009.184. Epub 2009 Nov 18.
PubMed 19924114
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol (CBD) on the Brain
- ClinicalTrials.gov ID
- NCT04831294
- Acronym / sponsor ID
- CBD / 20-107 MR 2003
- Conditions
- CBD, Fear, Inhibition
- Keywords
- cannabidiol, placebo, rct, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Folium Biosciences, FutureCeuticals
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol, Drug: PlaceboA 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. |
| Placebo | Placebo comparator | Drug: Cannabidiol, Drug: PlaceboA 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDAdministered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it. | Drug | Cannabidiol (CBD), Placebo |
| PlaceboAdministered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it. | Drug | Cannabidiol (CBD), Placebo |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 29887287Grimm O, Loffler M, Kamping S, Hartmann A, Rohleder C, Leweke M, Flor H. Probing the endocannabinoid system in healthy volunteers: Cannabidiol alters fronto-striatal resting-state connectivity. Eur Neuropsychopharmacol. 2018 Jul;28(7):841-849. doi: 10.1016/j.euroneuro.2018.04.004. Epub 2018 Jun 7.
- Background: PubMed 31013455Wall MB, Pope R, Freeman TP, Kowalczyk OS, Demetriou L, Mokrysz C, Hindocha C, Lawn W, Bloomfield MA, Freeman AM, Feilding A, Nutt D, Curran HV. Dissociable effects of cannabis with and without cannabidiol on the human brain's resting-state functional connectivity. J Psychopharmacol. 2019 Jul;33(7):822-830. doi: 10.1177/0269881119841568. Epub 2019 Apr 23.
- Background: PubMed 29682609Beale C, Broyd SJ, Chye Y, Suo C, Schira M, Galettis P, Martin JH, Yucel M, Solowij N. Prolonged Cannabidiol Treatment Effects on Hippocampal Subfield Volumes in Current Cannabis Users. Cannabis Cannabinoid Res. 2018 Apr 1;3(1):94-107. doi: 10.1089/can.2017.0047. eCollection 2018.
- Background: PubMed 31439831Wilson R, Bossong MG, Appiah-Kusi E, Petros N, Brammer M, Perez J, Allen P, McGuire P, Bhattacharyya S. Cannabidiol attenuates insular dysfunction during motivational salience processing in subjects at clinical high risk for psychosis. Transl Psychiatry. 2019 Aug 22;9(1):203. doi: 10.1038/s41398-019-0534-2.
- Background: PubMed 31994476O'Neill A, Wilson R, Blest-Hopley G, Annibale L, Colizzi M, Brammer M, Giampietro V, Bhattacharyya S. Normalization of mediotemporal and prefrontal activity, and mediotemporal-striatal connectivity, may underlie antipsychotic effects of cannabidiol in psychosis. Psychol Med. 2021 Mar;51(4):596-606. doi: 10.1017/S0033291719003519. Epub 2020 Jan 29.
- Background: PubMed 25249057Bhattacharyya S, Falkenberg I, Martin-Santos R, Atakan Z, Crippa JA, Giampietro V, Brammer M, McGuire P. Cannabinoid modulation of functional connectivity within regions processing attentional salience. Neuropsychopharmacology. 2015 May;40(6):1343-52. doi: 10.1038/npp.2014.258. Epub 2014 Sep 23.
- Background: PubMed 18589404Borgwardt SJ, Allen P, Bhattacharyya S, Fusar-Poli P, Crippa JA, Seal ML, Fraccaro V, Atakan Z, Martin-Santos R, O'Carroll C, Rubia K, McGuire PK. Neural basis of Delta-9-tetrahydrocannabinol and cannabidiol: effects during response inhibition. Biol Psychiatry. 2008 Dec 1;64(11):966-73. doi: 10.1016/j.biopsych.2008.05.011. Epub 2008 Jun 27.
- Background: PubMed 31129526Allendorfer JB, Nenert R, Bebin EM, Gaston TE, Grayson LE, Hernando KA, Houston JT, Hansen B, Szaflarski JP. fMRI study of cannabidiol-induced changes in attention control in treatment-resistant epilepsy. Epilepsy Behav. 2019 Jul;96:114-121. doi: 10.1016/j.yebeh.2019.04.008. Epub 2019 May 24.
- Background: PubMed 30167644Bhattacharyya S, Wilson R, Appiah-Kusi E, O'Neill A, Brammer M, Perez J, Murray R, Allen P, Bossong MG, McGuire P. Effect of Cannabidiol on Medial Temporal, Midbrain, and Striatal Dysfunction in People at Clinical High Risk of Psychosis: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Nov 1;75(11):1107-1117. doi: 10.1001/jamapsychiatry.2018.2309.
- Background: PubMed 31237191Pretzsch CM, Voinescu B, Mendez MA, Wichers R, Ajram L, Ivin G, Heasman M, Williams S, Murphy DG, Daly E, McAlonan GM. The effect of cannabidiol (CBD) on low-frequency activity and functional connectivity in the brain of adults with and without autism spectrum disorder (ASD). J Psychopharmacol. 2019 Sep;33(9):1141-1148. doi: 10.1177/0269881119858306. Epub 2019 Jun 25.
- Background: PubMed 17239356Hermann D, Sartorius A, Welzel H, Walter S, Skopp G, Ende G, Mann K. Dorsolateral prefrontal cortex N-acetylaspartate/total creatine (NAA/tCr) loss in male recreational cannabis users. Biol Psychiatry. 2007 Jun 1;61(11):1281-9. doi: 10.1016/j.biopsych.2006.08.027. Epub 2007 Jan 17.
- Background: PubMed 19124693Fusar-Poli P, Crippa JA, Bhattacharyya S, Borgwardt SJ, Allen P, Martin-Santos R, Seal M, Surguladze SA, O'Carrol C, Atakan Z, Zuardi AW, McGuire PK. Distinct effects of delta9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing. Arch Gen Psychiatry. 2009 Jan;66(1):95-105. doi: 10.1001/archgenpsychiatry.2008.519.
- Individual participant dataSharing planned: Undecided. 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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A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Active, not recruitingPhase 2
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Robinson, Ph.D. principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol in people with CBD and Fear, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831294, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.