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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
12
Single oral dose mephedrone Single oral dose alcohol
Single oral dose mephedrone
Single oral dose alcohol
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Barcelona, Spain
Change in drunkenness and drowsiness and effects
Drunkenness and drowsiness effects will be measured using rate scales (visual analogue scales).
Time frame: From pre-dose (baseline, 0h) to 6h post-dose
Change in other subjective effects
Subjective effects will be measured using rate 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 and alcohol.
Time frame: From pre-dose (baseline, 0h) to 6h post-dose
Change in blood pressure
Systolic and diastolic blood pressure
Time frame: From pre-dose (baseline, 0h) to 6h post-dose
Change in psychomotor function
Psychomotor function will be measured using Critical tracking task (CTT) and Divided Attention Task (DAT).
Time frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose
Change in memory function
Memory function will be measured using Spatial Memory Task (SMT).
Time frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of mephedrone and its metabolites in blood and urine.
Time frame: From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose
Area Under the Concentration-Time Curve (AUC 0-10h)
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Single oral dose placebo
Calculation of AUC of the concentrations of alcohol in blood.
Time frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h 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
Elimination hal-life
Calculation of elimination hal-life from concentrations of mephedrone and its metabolites in blood and urine.
Time frame: From pre-dose (baseline, 0h) to 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24h post-dose
Elimination hal-life
Calculation of elimination hal-life from concentrations of alcohol in blood.
Time frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose
Change in heart rate
Measure of heart rate
Time frame: From pre-dose (baseline, 0h) to 6h post-dose
Change in pupil diameter
Measure of pupil diameter
Time frame: From pre-dose (baseline, 0h) to 6h post-dose
Change in oral temperature
Measure of oral temperature
Time frame: From pre-dose (baseline, 0h) to 6h post-dose