Brain Kinetics of Neurotransmission During JWH-018 Intoxication
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Neurotransmission
研究概览
简要总结
The goal of this placebo-controlled study is to learn about the neural mechanisms underlying the acute effects of the synthetical cannabinoid JWH-018 in healthy, occasional cannabis users. It aims to assess neural underpinnings of neurocognitive impairments and psychotomimetic symptoms expected during the intoxication. Neuronal changes similar to those seen in cannabis intoxication are expected, such as altered neurotransmission and loss of functional connectivity within the mesocorticolimbic circuit. MRS, fMRI and blood parameters will be used for assessment. Participants will be asked to complete cognitive tasks and subjective questionnaires related to the subjective experience of the drug.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sufficient experience with cannabis
- •Age between 18 and 40 years
- •Free from psychotropic medication
- •Good physical health
- •Absence of any major medical, endocrine and neurological condition
- •Normal weight, body mass index (weight/height^2) between 18 and 28 kg/m^2
- •Written Informed Consent
- •Good knowledge and understanding of the English language
- •refrain from taking illicit psychoactive substances during the study
- •willing to drink only alcohol-free liquids and no caffeinated beverages from 24 hours prior to dosing day, as well as during the study day
- •Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
排除标准
- •History of drug addiction
- •Pregnancy or lactation or pregnancy planned during study participation
- •Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
- •Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
- •Any chronic or acute medical condition
- •History of cardiac dysfunctions (arrhythmia, ischemic heart disease,...)
- •For women: no use of a reliable contraceptive
- •Tobacco smoking (>20 per day)
- •Excessive drinking (>20 alcoholic consumptions per week)
- •Simultaneous participation in another clinical trial
- •fMRI contraindications
研究组 & 干预措施
JWH-018 condition
干预措施: JWH018 (Drug)
Placebo condition
干预措施: non-active control (no substance) (Other)
结局指标
主要结局
Neurotransmission
时间窗: up to 3.5 hours after drug administration
neurochemical concentration of glutamate, GABA and dopamine measured with MRS and resting-state fMRI
Functional connectivity
时间窗: during acute intoxication
Functional connectivity strength as measured by resting-state fMRI
次要结局
- sustained attention(up to 3.5 hours after intoxication)
- attentional salience processing(up to 3.5 hours after intoxication)
- Subjective drug effects - drug liking(up to 3.5 hours after intoxication)
- Subjective drug effects - subjective high(up to 3.5 hours after intoxication)
- false memory formation(up to 3.5 hours after intoxication)
- Subjective drug effects - dissociative state(up to 3.5 hours after intoxication)
- Subjective drug effects - psychedelic-like effects(up to 3.5 hours after intoxication)
- Subjective drug effects - Altered States of Consciousness Rating Scale (5D-ASC)(up to 3.5 hours after intoxication)
- Subjective drug effects - psychosis-like effects(up to 3.5 hours after intoxication)
- Subjective drug effects - retrospective drug reinforcement (RDRV)(up to 3.5 hours after intoxication)
- JWH-018 kinetics(baseline & regular intervals up to 3.5 hours after intoxication)
- Metabolomics(baseline & regular intervals up to 3.5 hours after intoxication)
- Inflammatory cytokines(at baseline & within 30 minutes after intoxication)