Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hopkins Verbal Learning Test
研究概览
简要总结
This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing.
Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device.
Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences.
The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo/THC
Oral placebo followed by inhalation of cannabis containing THC.
干预措施: Placebo (Drug)
Placebo/THC
Oral placebo followed by inhalation of cannabis containing THC.
干预措施: Delta-9-THC (Drug)
CBD/THC
Oral CBD 1000mg followed by inhalation of cannabis containing THC.
干预措施: Cannabidiol (Drug)
CBD/THC
Oral CBD 1000mg followed by inhalation of cannabis containing THC.
干预措施: Delta-9-THC (Drug)
结局指标
主要结局
Hopkins Verbal Learning Test
时间窗: Baseline visit; 20 mins post-THC
Delayed verbal recall
Positive and Negative Syndrome Scale
时间窗: pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC)
Positive Subscale
次要结局
- White Noise Task(Baseline visit; 50 mins post-THC)
- Plasma delta-9-tetrahydrocannabinol (THC) concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Plasma cannabidiol (CBD) concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Plasma 11-COOH-THC concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Plasma THC-COOH concentraion(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Plasma 6-OH-CBD concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- State-Trait Anxiety Inventory(pre-CBD/placebo administration, pre-THC and 20mins post-THC)
- Hopkins Verbal Learning Test(Baseline; 20 mins post-THC)
- Study drug preference(End of Experiment 2)
- Advice Taking Task(Baseline visit; 30 mins post-THC)
- State Social Paranoia Scale(pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC))
- Visual analogue scales(pre-CBD/placebo, 90mins post CBD, pre-THC, and +10mins, +45mins, +90mins post-THC inhalation, and at the end of study visit (i.e. 2-3 hours post-THC))
- Psychotomimetic states inventory(pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC))
- Plasma 11-OH-THC concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Digit span(Baseline; 25 mins post-THC)
- Positive and Negative Syndrome Scale(pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC))
- Plasma anandamide concentration(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
- Plasma 2-arachidonoylglycerol concentration.(pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC)
研究者
Dr Edward Chesney
Psychiatrist/Clinical Research Fellow/Study Co-ordinator
King's College London