Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Syndrome Scale (total score, PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and D2-receptor availability
研究概览
简要总结
The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Informed consent given by the subject
- •Healthy young man (age between 18 and 45) insightful to the study (WST> 95)
- •Right handedness
- •At least one time consumption of Cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse
- •Negative drug-screening at the time of screening
- •Body Mass Index between 18 and 30
排除标准
- •Lack of accountability
- •Participation in other interventional trials
- •Severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
- •Any known psychiatric illness in the participant's history
- •Known family history concerning psychiatric disorders
- •Cannabis consumption within the last six months
- •Consumption of any illegal drugs (except cannabis in history, see above)
- •Intake of interfering medication, at the discretion of the investigator
- •High intracranial pressure
- •Any disorders in stereoscopic vision (measured by the TNO-Test, Lamerics, Utrecht) or hearing deficits
- •Contraindications due to the Investigators Brochure Contraindication for Magnetic Resonance Imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like Phenprocoumon) or contradiction for the PET-CT method and the radiopharmaceutical
研究组 & 干预措施
THC
Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.
干预措施: Delta-9-tetrahydrocannabinol (Drug)
THC
Subjects receive 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each) and corresponding cannabidiol placebo capsules.
干预措施: Placebo (Drug)
CBD
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
干预措施: Cannabidiol (Drug)
CBD
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and corresponding delta-9-tetrahydrocannabinol placebo capsules.
干预措施: Placebo (Drug)
CBD+THC
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each)
干预措施: Delta-9-tetrahydrocannabinol (Drug)
CBD+THC
Subjects receive 800 mg cannabidiol (4 capsules containing 200 mg each) and 20 mg delta-9-tetrahydrocannabinol (2 capsules containing 10 mg each)
干预措施: Cannabidiol (Drug)
Placebo
Subjects receive corresponding delta-9-tetrahydrocannabinol and cannabidiol placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (total score, PANSS T) from baseline to post drug intake of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and D2-receptor availability
时间窗: up to 6 hours
次要结局
- Change in binocular depth inversion illusion (BDII)(up to 6 hours)
- Change in Wisconsin Card Sorting Test Performance(up to 6 hours)
- Change in PANSS subscores and clusters (baseline to post drug intake)(up to 4 hours)
- Change in Digit Symbol Coding(up to 6 hours)
- Metabolic markers post drug intake (blood)(up to 4 hours)
- Metabolic markers post drug intake (cerebrospinal fluid)(up to 4 hours)
- Change in Letter-Number-Sequencing(up to 6 hours)
- Change in emotional state (EWL, "Eigenschaftswörterliste")(up to 6 hours)
- Change in attentional state (d2-test of attention d2-R)(up to 6 hours)
- Change in imagination (Bett's Questionaire upon Mental Imagery)(up to 6 hours)
- Assessment of hallucinogenic states scale (APZ) (post drug intake)(1 day)
- Safety and tolerability assessments including (S)AEs, physical examination, vital signs (including heart rate and systolic and diastolic blood pressure in both supine and standing positions), and detailed laboratory assessments(1 day)
- D2-receptor availability post drug intake(up to 5 hours)