Investigating the Acute Effects of THC on Functional Brain Systems
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The main study parameter is the blood oxygen level dependent (BOLD) signal.
研究概览
简要总结
The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.
详细描述
Cannabis is by far the most frequently used illicit drug worldwide and has significant effects on memory. Further, cannabis has an addictive potential. These effects are mediated by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1 receptors. These receptors are particularly highly expressed in brain regions involved in memory and reward. Therefore, in this study we will investigate the acute effects of THC on functional brain systems underlying memory and reward. We will visualize these effects using the latest non-invasive imaging technique: pharmacological MRI (phMRI).
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •History of mild cannabis use for at least one year (<1/week and ≥ 4/year)
- •History without psychotic experiences after cannabis use
- •Age between 18 and 45 years
- •Right-handedness, assessed with the Edinburgh Handedness Inventory
- •Written informed consent of the subject
排除标准
- •Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
- •Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
- •History of clinically significant psychiatric or neurological illness
- •History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
- •History of alcohol and/or drug abuse (DSM-IV criteria)
- •Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2
- •Paranoid ideation or psychoticism on SCL-90
- •Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
- •The use of any medication within three weeks prior to the start of the study, except for paracetamol
- •Positive HIV or Hepatitis B/C test
- •Blood donation within 3 months before the start of the study
- •Claustrophobia
- •Metal objects in or around the body (braces, pacemaker, metal fragments)
研究组 & 干预措施
A
Inhalation of THC, using a Volcano vaporizer
干预措施: Delta9-tetrahydrocannabinol (THC) (Drug)
B
Inhalation of vehicle, using a Volcano vaporizer
干预措施: Delta9-tetrahydrocannabinol (THC) (Drug)
结局指标
主要结局
The main study parameter is the blood oxygen level dependent (BOLD) signal.
时间窗: 4 months
次要结局
- Performance on neuropsychological tests(4 months)
- Behavioral parameters (two VAS questionnaires)(4 months)
- Cerebral blood flow (ASL)(4 months)
- Concentration of plasma THC and its main metabolites(4 months)