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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
12
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Barcelona, Spain
Changes in blood pressure
Systolic and diastolic blood pressure
Time frame: From pre-dose (baseline) to 4h post-dose
Changes in euphoria-good effects
Euphoria-good effects effects will be measured using rating scales (visual analogue scales, the Addiction Research Center Inventory and the Evaluation of the Subjective Effects of Substances with Abuse Potential questionnaires). All these instruments include measures of euphoria-good effects and other feelings induced by psychostimulants
Time frame: From pre-dose (baseline) to 4h post-dose
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of mephedrone and MDMA and its metabolites in blood, urine, oral fluid and sweat.
Time frame: 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
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
Time frame: 7 days after each substance administration
Elimination half-life
Calculation of elimination hal-life from concentrations of mephedrone, MDMA and its metabolites in plasma-blood, urine, oral fluid and sweat.
Time frame: From baseline to 24h post-dose
Changes in heart rate
Measure of heart rate (pulse)
Time frame: From pre-dose (baseline) to 4h post-dose
Changes in pupil diameter
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Measure of pupil diameter and capacity of convergence (esophoria) using a pupillometer
Time frame: From pre-dose (baseline) to 4h post-dose
Changes in oral temperature
Measure of temperature in mouth using automatic thermometer
Time frame: From pre-dose (baseline) to 4h post-dose