Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale for Schizophrenia (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 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 naive
- •Individuals with a documented reaction/allergy to Pregnenolone
研究组 & 干预措施
Placebo Delta-9-THC and Active Pregnenolone
干预措施: Placebo (Drug)
Active Delta-9-THC and Placebo Pregnenolone
干预措施: Placebo (Drug)
Active Delta-9-THC and Active Pregnenolone
干预措施: Active Delta-9-THC (Drug)
Active Delta-9-THC and Placebo Pregnenolone
干预措施: Active Delta-9-THC (Drug)
Active Delta-9-THC and Active Pregnenolone
干预措施: Active Pregnenolone (Drug)
Placebo Delta-9-THC and Active Pregnenolone
干预措施: Active Pregnenolone (Drug)
Placebo Delta-9-THC and Placebo Pregnenolone
干预措施: Placebo (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
时间窗: Baseline, +110, +180, and +240 minutes after start of THC Infusion
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS.
次要结局
- Clinician Administered Dissociative Symptoms Scale (CADSS)(Baseline; +15, +110, +180, and +240 minutes after start of THC infusion)
- Psychotomimetic States Inventory (PSI)(Baseline; +110, +180, and +240 minutes after start of THC infusion)
- Visual Analog Scale (VAS)(Baseline; +15, +110, +180, and +240 minutes after start of THC infusion)
- Cognitive Test Battery(25 minutes after start of THC infusion)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University