Abuse Liability and Human Pharmacology of Mephedrone (4-methylmethcathinone,4-MMC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in blood pressure
研究概览
简要总结
The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
详细描述
Mephedrone is a new psychoactive substance (NPS). At present, there are no randomized controlled trials evaluating the effects of mephedrone in humans. The current body of knowledge regarding the acute effects of mephedrone is based on anecdotal, self-reported effects (e.g. internet forums), case reports, and emergency room series and fatalities.
The aims of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Understanding and accepting the study procedures and signing the informed consent.
- •Male adults volunteers (18-45 years old).
- •Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- •The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- •Recreational use of amphetamines, ecstasy and hallucinogen derivatives, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without serious adverse reactions.
- •Extensive metabolizer or intermediate metabolizer phenotype for cytochrome P-450-2D6 (CYP2D6) activity determined using dextromethorphan as a selective probe drug.
- •The weight does not exceed 15% of ideal weight that applies according to size and will be between 60 and 100 Kg. Minor variations will be accepted as normal limits, if the researchers considered it clinically insignificant.
排除标准
- •Daily consumption >20 cigarettes and >4 standard units of ethanol.
- •Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- •Presence of major psychiatric disorders.
- •Present history of abuse or drug dependence (except for nicotine dependence).
- •Past history of drug dependence (except for nicotine dependence). Subjects with past history of drug abuse could be included.
- •Having suffered any organic disease or major surgery in the three months prior to the study start.
- •Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 4 weeks.
- •Subjects with intolerance or serious adverse reactions to drugs or amphetamines, ecstasy and hallucinogen derivatives, mephedrone or other cathinone.
- •History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- •Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- •Subjects with positive serology to Hepatitis B, C or HIV.
研究组 & 干预措施
Mephedrone
Mephedrone 200 mg, single dose, oral administration
干预措施: Mephedrone (Drug)
3,4-methylenedioxymethamphetamine
3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration
干预措施: 3,4-methylenedioxymethamphetamine (Drug)
Lactose
Placebo, single dose, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in blood pressure
时间窗: From pre-dose (baseline) to 4h post-dose
Systolic and diastolic blood pressure
次要结局
- Changes in heart rate(From pre-dose (baseline) to 4h post-dose)
- Changes in euphoria-good effects(From pre-dose (baseline) to 4h post-dose)
- Area Under the Concentration-Time Curve (AUC 0-24h)(From baseline (pre-dose, 0h) to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24h post-dose)
- Elimination half-life(From baseline to 24h post-dose)
- Changes in pupil diameter(From pre-dose (baseline) to 4h post-dose)
- Number of Participants with Serious and Non-Serious Adverse Events(7 days after each substance administration)
- Changes in oral temperature(From pre-dose (baseline) to 4h post-dose)