Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposed to cannabis at least once in lifetime
排除标准
- •Cannabis naïve
- •Individuals with a documented reaction/allergy to Pregnenolone
- •Individuals with a documented reaction/allergy to Sesame oil
研究组 & 干预措施
Placebo THC and Active Pregnenolone
干预措施: Active Pregnenolone (Drug)
Active THC and Placebo Pregnenolone
干预措施: Active Dronabinol (Drug)
Active THC and Placebo Pregnenolone
干预措施: Placebo Pregnenolone (Drug)
Active THC and Active Pregnenolone
干预措施: Active Dronabinol (Drug)
Active THC and Active Pregnenolone
干预措施: Active Pregnenolone (Drug)
Placebo THC and Active Pregnenolone
干预措施: Placebo Dronabinol (Drug)
Placebo THC and Placebo Pregnenolone
干预措施: Placebo Dronabinol (Drug)
Placebo THC and Placebo Pregnenolone
干预措施: Placebo Pregnenolone (Drug)
结局指标
主要结局
Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
时间窗: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.
次要结局
- Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)(baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo)
- Change from Baseline: Psychotomimetic States Inventory (PSI)(baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo)
- Change from Baseline: Visual Analog Scale (VAS)(Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo)
- Cognitive Test Battery(25 minutes after Dronabinol is given orally)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University