Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abuse Liability and Human Pharmacology of Mephedrone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232789
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
Changes in blood pressure [ Time Frame: From pre-dose (baseline) to 4h post-dose ]
Systolic and diastolic blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abuse Liability and Human Pharmacology of Mephedrone
Official Title  ICMJE 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 Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Amphetamine-Related Disorders
Intervention  ICMJE
  • Drug: Mephedrone
    Single oral dose mephedrone
    Other Names:
    • 4-methylmethcathinone
    • 4-MMC
  • Drug: 3,4-methylenedioxymethamphetamine
    Single oral dose MDMA
    Other Names:
    • MDMA
    • Ecstasy
  • Drug: Placebo
    Single oal dose placebo
    Other Name: Non active treatment
Study Arms  ICMJE
  • Experimental: Mephedrone
    Mephedrone 200 mg, single dose, oral administration
    Intervention: Drug: Mephedrone
  • Active Comparator: 3,4-methylenedioxymethamphetamine
    3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration
    Intervention: Drug: 3,4-methylenedioxymethamphetamine
  • Placebo Comparator: Lactose
    Placebo, single dose, oral administration
    Intervention: Drug: Placebo
Publications * Papaseit E, Pérez-Mañá C, Mateus JA, Pujadas M, Fonseca F, Torrens M, Olesti E, de la Torre R, Farré M. Human Pharmacology of Mephedrone in Comparison with MDMA. Neuropsychopharmacology. 2016 Oct;41(11):2704-13. doi: 10.1038/npp.2016.75. Epub 2016 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Understanding and accepting the study procedures and signing the informed consent.
  • Male adults volunteers (18-45 years old).
  • Clinical history and physical examination demonstrating no organic or psychiatric disorders.
  • The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
  • Recreational use of amphetamines, ecstasy and hallucinogen derivatives, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without serious adverse reactions.
  • Extensive metabolizer or intermediate metabolizer phenotype for cytochrome P-450-2D6 (CYP2D6) activity determined using dextromethorphan as a selective probe drug.
  • The weight does not exceed 15% of ideal weight that applies according to size and will be between 60 and 100 Kg. Minor variations will be accepted as normal limits, if the researchers considered it clinically insignificant.

Exclusion Criteria:.

  • Daily consumption >20 cigarettes and >4 standard units of ethanol.
  • Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
  • Presence of major psychiatric disorders.
  • Present history of abuse or drug dependence (except for nicotine dependence).
  • Past history of drug dependence (except for nicotine dependence). Subjects with past history of drug abuse could be included.
  • Having suffered any organic disease or major surgery in the three months prior to the study start.
  • Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 4 weeks.
  • Subjects with intolerance or serious adverse reactions to drugs or amphetamines, ecstasy and hallucinogen derivatives, mephedrone or other cathinone.
  • History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
  • Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
  • Subjects with positive serology to Hepatitis B, C or HIV.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232789
Other Study ID Numbers  ICMJE IMIMFTCL/MEF/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Magi Farre, MD, PhD Parc de Salut Mar
PRS Account Parc de Salut Mar
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP