Clinical Trial: Mephedrone and Alcohol Interactions in Humans

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

Official Title: Mephedrone and Alcohol Interactions After Single-dose Administration in Humans

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Parc de Salut Mar

Current Primary Outcome: Change in drunkenness and drowsiness and effects [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in other subjective effects [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]
  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.
• Change in blood pressure [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]
  Systolic and diastolic blood pressure
• Change in psychomotor function [ Time Frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose ]
  Psychomotor function will be measured using Critical tracking task (CTT) and Divided Attention Task (DAT).
• Change in memory function [ Time Frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose ]
  Memory function will be measured using Spatial Memory Task (SMT).
• Area Under the Concentration-Time Curve (AUC 0-24h) [ 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 ]
  Calculation of AUC of the concentrations of mephedrone and its metabolites in blood and urine.
• Area Under the Concentration-Time Curve (AUC 0-10h) [ Time Frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose ]
  Calculation of AUC of the concentrations of alcohol in blood.
• Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 7 days after each ]
  Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators.
• Elimination hal-life [ 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 ]
  Calculation of elimination hal-life from concentrations of mephedrone and its metabolites in blood and urine.
• Elimination hal-life [ Time Frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose ]
  Calculation of elimination hal-life from concentrations of alcohol in blood.
• Change in heart rate [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]
  Measure of heart rate
• Change in pupil diameter [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]
  Measure of pupil diameter
• Change in oral temperature [ Time Frame: From pre-dose (baseline, 0h) to 6h post-dose ]
  Measure of oral temperature

Original Secondary Outcome: Same as current

Information By: Parc de Salut Mar

Dates:
Date Received: November 17, 2014
Date Started: December 2014
Date Completion:
Last Updated: October 7, 2015
Last Verified: October 2015