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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of CBD-Rich Oil on Aversive Memory Reconsolidation

NCT04726475

Anxiety and Fear

UNKNOWN PHASE1/PHASE2

The Effect of Cannabidiol in Learning and Memory of Adults

NCT06074172

Memory

COMPLETED PHASE2

Use of CBD in the Treatment of Anxiety

NCT06672666

Anxiety Generalized Anxiety Disorder Sleep Problems

RECRUITING PHASE2

4 Week Veterans Cannabidiol Intervention

NCT05850754

Healthy

ACTIVE_NOT_RECRUITING NA

Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)

NCT05023759

Generalized Anxiety Disorder

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBD-WR

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.

Group Type EXPERIMENTAL

Trauma Memory Reactivation

Intervention Type BEHAVIORAL

Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.

Cannabidiol (CBD) Broad-Spectrum Oil

Intervention Type DIETARY_SUPPLEMENT

300mg CBD broad-spectrum oil.

PBO-WR

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.

Group Type PLACEBO_COMPARATOR

Trauma Memory Reactivation

Intervention Type BEHAVIORAL

Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.

Placebo Oil

Intervention Type DIETARY_SUPPLEMENT

3ml oral dose of medium-chain triglycerides (MCT) coconut oil.

CBD-OR

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.

Group Type ACTIVE_COMPARATOR

Trauma Memory Reactivation

Intervention Type BEHAVIORAL

Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.

Cannabidiol (CBD) Broad-Spectrum Oil

Intervention Type DIETARY_SUPPLEMENT

300mg CBD broad-spectrum oil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trauma Memory Reactivation

Participants will be guided through the trauma memory reactivation paradigm by the study staff. The trauma memory reactivation paradigm entails two distinct procedures: (1) participants will watch a video clip related to their trauma; then (2) describe a verbal narrative of their traumatic event for approximately 5 minutes to a research team member.

Intervention Type BEHAVIORAL

Cannabidiol (CBD) Broad-Spectrum Oil

300mg CBD broad-spectrum oil.

Intervention Type DIETARY_SUPPLEMENT

Placebo Oil

3ml oral dose of medium-chain triglycerides (MCT) coconut oil.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No