Effects of Cannabidiol on Memory Reconsolidation and Trauma-Related Symptoms: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Momentary Assessment of Distress Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Trauma Memory Reactivation (Behavioral)
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.
干预措施: Cannabidiol (CBD) Broad-Spectrum Oil (Dietary Supplement)
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.
干预措施: Trauma Memory Reactivation (Behavioral)
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.
干预措施: Placebo Oil (Dietary Supplement)
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.
干预措施: Trauma Memory Reactivation (Behavioral)
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.
干预措施: Cannabidiol (CBD) Broad-Spectrum Oil (Dietary Supplement)
结局指标
主要结局
Momentary Assessment of Distress Scale
时间窗: Change from Baseline to Two-week Follow-up
The Momentary Assessment of Distress Scale (MADS) is a customizable sliding scale used to measure continuous real-time changes in levels of subjective emotional stress on scale from 0 (no distress) to 10 (extreme distress). The MADS is used to index changes in emotional reactivity during exposure to a trauma memory reactivation cue.
次要结局
- Posttraumatic Stress Disorder Checklist(Change from Baseline to Two-week Follow-up)
- Posttraumatic Growth Inventory(Change from Baseline to Two-week Follow-up)
- Connor-Davidson Resilience Scale(Change from Baseline to Two-week Follow-up)
- Posttraumatic Cognition Inventory(Change from Baseline to Two-week Follow-up)
- Posttraumatic Safety Behaviors Inventory(Change from Baseline to Two-week Follow-up)
- Trauma Coping Self-Efficacy Scale(Change from Baseline to Two-week Follow-up)
研究者
Michael J. Telch
Professor of Clinical Psychology
University of Texas at Austin