Abuse Liability and Human Pharmacology of Mephedrone
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|ClinicalTrials.gov Identifier: NCT02232789|
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : December 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amphetamine-Related Disorders||Drug: Mephedrone Drug: 3,4-methylenedioxymethamphetamine Drug: Placebo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Abuse Liability and Human Pharmacology of Mephedrone (4-methylmethcathinone,4-MMC)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Mephedrone 200 mg, single dose, oral administration
Single oral dose mephedrone
Active Comparator: 3,4-methylenedioxymethamphetamine
3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration
Single oral dose MDMA
Placebo Comparator: Lactose
Placebo, single dose, oral administration
Single oal dose placebo
Other Name: Non active treatment
- Changes in blood pressure [ Time Frame: From pre-dose (baseline) to 4h post-dose ]Systolic and diastolic blood pressure
- Changes in euphoria-good effects [ Time Frame: From pre-dose (baseline) to 4h post-dose ]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
- Area Under the Concentration-Time Curve (AUC 0-24h) [ 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 ]Calculation of AUC of the concentrations of mephedrone and MDMA and its metabolites in blood, urine, oral fluid and sweat.
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 7 days after each substance administration ]Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
- Elimination half-life [ Time Frame: From baseline to 24h post-dose ]Calculation of elimination hal-life from concentrations of mephedrone, MDMA and its metabolites in plasma-blood, urine, oral fluid and sweat.
- Changes in heart rate [ Time Frame: From pre-dose (baseline) to 4h post-dose ]Measure of heart rate (pulse)
- Changes in pupil diameter [ Time Frame: From pre-dose (baseline) to 4h post-dose ]Measure of pupil diameter and capacity of convergence (esophoria) using a pupillometer
- Changes in oral temperature [ Time Frame: From pre-dose (baseline) to 4h post-dose ]Measure of temperature in mouth using automatic thermometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232789
|Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.|
|Barcelona, Spain, 08003|
|Principal Investigator:||Magi Farre, MD, PhD||Parc de Salut Mar|