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Cannabinoid
CBD on Brain Function (CBD Trial)
N/A
Waitlist Available
Led By Jennifer L Robinson, Ph.D.
Research Sponsored by Auburn University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Awards & highlights
Summary
This trial will examine the acute effects of CBD on the brain. 100% THC-free CBD will be compared to placebo, and participants will be scanned before and after ingestion. Results will help to determine if CBD has any neurometabolic or neurophysiological effects, and if it affects working memory or response inhibition.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While CBD is generally considered safe and non-addictive, potential side effects may include changes in alertness, gastrointestinal discomfort, mood swings, drowsiness, dry mouth, or low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
BOLD - Change in Threat Response to Subliminal Emotion Stimuli
Behavioral Measures - Change in Go/No-Go Accuracy
Behavioral Measures - Change in Go/NoGo Reaction Time
+5 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761729%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Cannabidiol
FDA approved
Find a Location
Who is running the clinical trial?
Folium BiosciencesUNKNOWN
Auburn UniversityLead Sponsor
78 Previous Clinical Trials
14,570 Total Patients Enrolled
FutureCeuticalsUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You primarily use your right hand for tasks.You are between 21-50 years old.You have exercised within an hour before the scan.You are currently taking medications for mental health or neurological conditions.You have a history of heart disease or stroke.You have diabetes or other conditions that affect your metabolism.You have had previous head injuries, like concussions.You have taken pain relievers within the 12 hours before the scan.You have used or are currently taking THC or CBD.You do not currently have any psychiatric or neurological disorders.You are between 21 and 50 years old.You have been diagnosed with a mental or neurological condition.You have had alcohol within the last 24 hours before getting a scan.You have no previous history of cardiac issues or cerebrovascular accidents.You must pass a test to make sure it's safe for you to be in the MRI machine.You do not have any current mental or brain-related conditions.You have never had heart disease or a stroke.You are in good overall health.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cannabidiol (CBD)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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