跳至主要内容
临床试验/NCT04871269
NCT04871269进行中(未招募)不适用

The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
291
试验地点
1
主要终点
Change of Intrusive Memories in the following four days after the intervention

研究概览

简要总结

The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

详细描述

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD) after traumatic events. In own of our own studies, we found reduced concentrations of the endocannabinoid arachidonylethanolamide (AEA) in BPD patients compared to healthy women (see Fig 1a). Furthermore, we found a correlation between hair concentrations of AEA and cortisol (p = .06; Fig 1b).

Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. In consequence, increased endocannabinoid signaling during acquisition and consolidation of traumatic events might be a promising approach to prevent the development of PTSD. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma.

A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.

This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy female volunteers
  • German on a native level

排除标准

  • former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
  • any physical illnesses
  • any medication intake (except oral contraceptive)
  • history of traumatic experience, e.g. history of sexual abuse or rape
  • pregnancy or lactation period
  • follicular phase of menstrual cycle for all women not using oral contraceptives

研究组 & 干预措施

Drug: Dronabinol before the trauma film paradigm

Experimental

干预措施: Dronabinol (Drug)

Drug: Dronabinol before the trauma film paradigm

Experimental

干预措施: Placebo (Drug)

Drug: Dronabinol after the trauma film paradigm

Experimental

干预措施: Dronabinol (Drug)

Drug: Dronabinol after the trauma film paradigm

Experimental

干预措施: Placebo (Drug)

Placebo before and after the trauma film paradigm

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change of Intrusive Memories in the following four days after the intervention

时间窗: four consecutive days

Influence of dronabinol on the development of intrusive memories measured with an intrusion diary

次要结局

  • Noradrenergic System (measured with salivary alpha-amylase - u/ml)(Day 1)
  • Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)(Time Frame: Day 1)
  • Polygenic Risk Score Influence of polygenic risk score on development of intrusive memories(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Roepke

Prof. Dr.

Charite University, Berlin, Germany

研究点 (1)

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