Clinical Trial: Abuse Liability and Human Pharmacology of Mephedrone

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Abuse Liability and Human Pharmacology of Mephedrone (4-methylmethcathinone,4-MMC)

Brief Summary: 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).

Detailed Summary:

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).


Sponsor: Parc de Salut Mar

Current Primary Outcome: Changes in blood pressure [ Time Frame: From pre-dose (baseline) to 4h post-dose ]

Systolic and diastolic blood pressure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Parc de Salut Mar

Dates:
Date Received: August 29, 2014
Date Started: September 2014
Date Completion:
Last Updated: December 3, 2014
Last Verified: December 2014