Cannabidiol for CBD

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CBD+2 More
Cannabidiol - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • CBD
  • Fear
  • Inhibitions

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: Collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

Hour 72
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
Behavioral Measures - Change in N-back Accuracy
Behavioral Measures - Change in N-back Reaction Time
Blood Oxygen Level Dependent (BOLD) Changes
Change in Concentration of Neurometabolites
Changes in Functional Connectivity

Trial Safety

Safety Progress

1 of 3

Side Effects for

Cannabidiol
60%Temporary increased seizures
40%Behavioral Issues
20%Increased aspartate aminotransferase liver function test
20%Right eye exotropia and redness/intermittent exotropia without redness
20%Facial Skin Infection
20%Tiredness
20%Left Eye Vertical Nystagmus
20%Pneumonia
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02332655) in the Cannabidiol ARM group. Side effects include: Temporary increased seizures with 60%, Behavioral Issues with 40%, Increased aspartate aminotransferase liver function test with 20%, Right eye exotropia and redness/intermittent exotropia without redness with 20%, Facial Skin Infection with 20%.

Trial Design

2 Treatment Groups

Cannabidiol (CBD)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

15 Total Participants · 2 Treatment Groups

Primary Treatment: Cannabidiol · Has Placebo Group · N/A

Cannabidiol (CBD)Experimental Group · 2 Interventions: Cannabidiol, Placebo · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Cannabidiol, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: collected pre-drug, post-drug, pre-placebo, and post-placebo; through study completion (4 time points over a 72 hour period)

Who is running the clinical trial?

Auburn UniversityLead Sponsor
51 Previous Clinical Trials
13,522 Total Patients Enrolled
Folium BiosciencesUNKNOWN
FutureCeuticalsUNKNOWN
Jennifer L Robinson, Ph.D.Principal InvestigatorAuburn University
1 Previous Clinical Trials
8 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a chronological age of at least 21 years.
There are no current psychiatric or neurological conditions.
They have no history of heart disease or stroke.
You are right-handed.
You have a blood count that is generally normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How old are they?
18 - 65100.0%
References