Clinical trial NCT05892276: Effects of CBD Oil on Memory Reconsolidation and Trauma-Related Symptoms
Official title: Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Cannabidiol
CBD
PTSD
Trauma
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Momentary Assessment of Distress Scale
timeFrame: Change from Baseline to Two-week Follow-up
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Cognition Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Safety Behaviors Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Posttraumatic Growth Inventory
timeFrame: Change from Baseline to Two-week Follow-up
measure: Trauma Coping Self-Efficacy Scale
timeFrame: Change from Baseline to Two-week Follow-up
measure: Connor-Davidson Resilience Scale
timeFrame: Change from Baseline to Two-week Follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: The Laboratory for the Study of Anxiety Disorders, The University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Michael J Telch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler RC, Aguilar-Gaxiola S, Alonso J, Benjet C, Bromet EJ, Cardoso G, Degenhardt L, de Girolamo G, Dinolova RV, Ferry F, Florescu S, Gureje O, Haro JM, Huang Y, Karam EG, Kawakami N, Lee S, Lepine JP, Levinson D, Navarro-Mateu F, Pennell BE, Piazza M, Posada-Villa J, Scott KM, Stein DJ, Ten Have M, Torres Y, Viana MC, Petukhova MV, Sampson NA, Zaslavsky AM, Koenen KC. Trauma and PTSD in the WHO World Mental Health Surveys. Eur J Psychotraumatol. 2017 Oct 27;8(sup5):1353383. doi: 10.1080/20008198.2017.1353383. eCollection 2017.
citation: Murkar A, Kent P, Cayer C, James J, Durst T, Merali Z. Cannabidiol and the Remainder of the Plant Extract Modulate the Effects of Delta9-Tetrahydrocannabinol on Fear Memory Reconsolidation. Front Behav Neurosci. 2019 Aug 1;13:174. doi: 10.3389/fnbeh.2019.00174. eCollection 2019.
citation: Stern CAJ, de Carvalho CR, Bertoglio LJ, Takahashi RN. Effects of Cannabinoid Drugs on Aversive or Rewarding Drug-Associated Memory Extinction and Reconsolidation. Neuroscience. 2018 Feb 1;370:62-80. doi: 10.1016/j.neuroscience.2017.07.018. Epub 2017 Jul 17.