Activation of the Endocannabinoid System and Cognition (Effekte Einer Akuten Aktivierung Des Cannabinoid-Systems Auf Kognitive Funktionen)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- extinction learning
研究概览
简要总结
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.
详细描述
Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). 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, i.e., delta-9-tetrahydrocannabinol) on tfear conditioning in patients with PTSD and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
blinding
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
- 是
入选标准
- •PTSD criteria fullfilled (patients only)
排除标准
- •All cases of physical illnesses and intake of medication (except oral contraceptives) (healthy controls only) will be excluded.
- •Pregnant and lactating individuals will also be excluded. Participants with a positive urinary cannabinoid test (Cannabis 20 Pipettier-Drogenschnelltest (Urin), Diagnostik Nord GmbH) will also be excluded.
- •psychiatric disorder according to DSM-5 (healthy controls only)
研究组 & 干预措施
Dronabinol PTSD
Donabinol before cognitve testing - PTSD patients
干预措施: Dronabinol 2.5 mg (Drug)
Dronabinol healthy controls
Donabinol before cognitve testing - healthy controls
干预措施: Dronabinol 2.5 mg (Drug)
Placebo PTSD
Placebo before cognitve testing - PTSD patients
干预措施: Placebo (Drug)
Placebo healthy controls
Placebo before cognitve testing - healthy controls
干预措施: Placebo (Drug)
结局指标
主要结局
extinction learning
时间窗: 30 minutes
extinction learning in fear conditioning paradigm: skin conductance reaction
次要结局
- selective attention(10 minutes)
- empathy(15 minutes)
- Probabilistic Reversal Learning Task(15 minutes)
研究者
Stefan Roepke
Prof. Dr. Stefan Röpke
Charite University, Berlin, Germany