Mephedrone and Alcohol Interactions After Single-dose Administration in Humans
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
- Change in drunkenness and drowsiness and effects
研究概览
简要总结
The purposes of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.
详细描述
Mephedrone (4-methylmetcathinone, 4-MMC) is a new psychoactive substance (NPS). Mephedrone is frequently used in combination with alcohol. At present, the effects of the interaction between mephedrone and alcohol in humans have not been previously evaluated in randomized controlled clinical trials.
The aims of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, 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
- •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 derivate, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without any adverse reactions.
- •Recreational use of alcohol (ethanol). Previous experience in acute alcohol intoxication.
- •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
- •Not meeting the inclusion criteria.
- •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). 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 derivate, 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 and alcohol
Mephedrone 200 mg, single dose, oral administration
Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration
干预措施: Mephedrone and alcohol (Drug)
Mephedrone
Mephedrone 200 mg, single dose, oral administration
Lemon-flavoured water (350 ml), single dose, oral administration
干预措施: Mephedrone (Drug)
Alcohol
Lactose 200 mg, single dose, oral administration
Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration
干预措施: Alcohol (Drug)
Placebo
Lactose 200 mg, single dose, oral administration
Lemon-flavoured water (350 ml), single dose, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change in drunkenness and drowsiness and effects
时间窗: From pre-dose (baseline, 0h) to 6h post-dose
Drunkenness and drowsiness effects will be measured using rate scales (visual analogue scales).
次要结局
- Change in other subjective effects(From pre-dose (baseline, 0h) to 6h post-dose)
- Change in blood pressure(From pre-dose (baseline, 0h) to 6h post-dose)
- Area Under the Concentration-Time Curve (AUC 0-24h)(From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose)
- Number of Participants with Serious and Non-Serious Adverse Events(7 days after each)
- Change in pupil diameter(From pre-dose (baseline, 0h) to 6h post-dose)
- Change in psychomotor function(From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose)
- Change in memory function(From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose)
- Area Under the Concentration-Time Curve (AUC 0-10h)(From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose)
- Elimination hal-life(From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose)
- Change in heart rate(From pre-dose (baseline, 0h) to 6h post-dose)
- Change in oral temperature(From pre-dose (baseline, 0h) to 6h post-dose)