Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms

The University of Texas System (UT)

Status: Withdrawn

Conditions: Posttraumatic Stress Disorder

Treatments: Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil; Behavioral: Trauma Memory Reactivation; Dietary Supplement: Placebo Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05892276

STUDY00004278

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults age 18 to 65;
• Fluent in written and spoken English;
• Has access to the internet;
• Access to a camera with video recording capability;
• History of trauma exposure to either a motor vehicle collision (MVC), sexual assault, physical assault, or combat;
• Willingness to refrain from all non-study cannabis use during the study period

Exclusion criteria

• Insufficient emotional reactivity to trauma video clips
• Presence of significant suicidality or a history of a suicide attempt within the past 6 months;
• History or current alcohol or substance use disorder within the past month;
• History of psychosis within the past 6 months;
• Changes in psychotropic medication (≤ 8 weeks);
• Currently receiving trauma-focused psychotherapy;
• Any medical problem that would preclude participation in the study (e.g., liver or renal abnormalities or disease);
• Any current medication that would preclude participation in the study (e.g., use of prescribed blood, such as warfarin; use of anti-seizure medications, such as valproate, lamotrigine, or clobazam; use of thyroid medications, such as levothyroxine; use of heart rhythm medications, such as amiodarone);
• Pregnant or planning to become pregnant within the next 6 weeks;
• Regular cannabis use;
• History of adverse reaction to CBD oil or other CBD products;
• Allergy to coconut or coconut oil

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

CBD-WR

Experimental group

Description:

300 mg CBD broad-spectrum oil will be administered within the reconsolidation window. Preclinical studies demonstrate that the disruptive effects of CBD oil on memory reconsolidation depend on the timing of pharmacological administration (within 6 hours of memory reactivation). Thus, participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil immediately after the trauma memory reactivation procedure.

Treatment:

Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil

Behavioral: Trauma Memory Reactivation

PBO-WR

Placebo Comparator group

Description:

Placebo oil will be administered within the reconsolidation window. Participants will be asked to take a single dose of an MCT coconut oil placebo solution immediately after the trauma memory reactivation procedure.

Treatment:

Behavioral: Trauma Memory Reactivation

Dietary Supplement: Placebo Oil

CBD-OR

Active Comparator group

Description:

300mg CBD broad-spectrum oil will be administered outside of the reconsolidation window. Participants will be asked to take a single 300mg oral dose of CBD broad-spectrum oil approximately 24 hrs after the trauma memory reactivation procedure. Thus, CBD will be administered well beyond the critical period for memory reconsolidation. The inclusion of this third arm provides a more robust test of the specific reconsolidation theory-based study hypotheses and aids in controlling for any nonspecific possible anxiolytic effects of CBD.

Treatment:

Dietary Supplement: Cannabidiol (CBD) Broad-Spectrum Oil

Behavioral: Trauma Memory Reactivation