Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892276
Status:
WITHDRAWN
Last Update Posted:
2024-01-09
First Post:
2023-05-15
Brief Title:
Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms A Randomized Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The UT IRB determined that CBD oil is being used as a drug as defined by the FDA Therefore an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations 21 CFR 312
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of cannabidiol CBD broad-spectrum oil on memory reconsolidation memory storage and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation paradigm
Detailed Description:
It is estimated that over 70 of individuals worldwide have experienced a trauma during their lifetime Many people spontaneously recover without formal intervention or treatment after exposure to a traumatic event however some individuals may develop intrusive trauma-related memories avoidance negative changes in cognition or mood or changes in arousal and reactivity resulting in clinical or subclinical symptoms of posttraumatic stress disorder PTSD
Recently the potential therapeutic effects of cannabidiol CBD have been investigated as a treatment for physical and mental health issues Preclinical trials with rodents suggest that CBD may disrupt the reconsolidation of conditioned fear memories when administered within the six-hour memory reconsolidation window These preclinical findings suggest that CBD may be clinically useful for preventing or treating PTSD Although promising little translational research has investigated the disruptive effects of CBD on memory reconsolidation in a trauma-exposed human population
The overarching objective of this study is to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation procedure To accomplish this participants will be randomized to one of three treatment conditions a CBD oil administered within the reconsolidation window CBD-WR b placebo oil administered within the reconsolidation window PBO-WR or c CBD oil administered well outside of the accepted memory reconsolidation window CBD-OR Participants will undergo a trauma memory reactivation paradigm rate their emotional distress level and complete other trauma-related measures
To the best of our knowledge this is the first clinical trial to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms among trauma-exposed individuals following exposure to a trauma memory reactivation paradigm Additionally this proof-of-concept pilot trial aims to contribute to the development of a novel brief packageable and cost-effective secondary prevention or treatment for individuals with trauma-related fear memories and symptoms of trauma
Recently the potential therapeutic effects of cannabidiol CBD have been investigated as a treatment for physical and mental health issues Preclinical trials with rodents suggest that CBD may disrupt the reconsolidation of conditioned fear memories when administered within the six-hour memory reconsolidation window These preclinical findings suggest that CBD may be clinically useful for preventing or treating PTSD Although promising little translational research has investigated the disruptive effects of CBD on memory reconsolidation in a trauma-exposed human population
The overarching objective of this study is to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms in trauma-exposed individuals after exposure to a trauma memory reactivation procedure To accomplish this participants will be randomized to one of three treatment conditions a CBD oil administered within the reconsolidation window CBD-WR b placebo oil administered within the reconsolidation window PBO-WR or c CBD oil administered well outside of the accepted memory reconsolidation window CBD-OR Participants will undergo a trauma memory reactivation paradigm rate their emotional distress level and complete other trauma-related measures
To the best of our knowledge this is the first clinical trial to investigate the effects of CBD broad-spectrum oil on memory reconsolidation and trauma-related symptoms among trauma-exposed individuals following exposure to a trauma memory reactivation paradigm Additionally this proof-of-concept pilot trial aims to contribute to the development of a novel brief packageable and cost-effective secondary prevention or treatment for individuals with trauma-related fear memories and symptoms of trauma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None