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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

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).

Condition or disease Intervention/treatment Phase
Amphetamine-Related Disorders Drug: Mephedrone Drug: 3,4-methylenedioxymethamphetamine Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arm Intervention/treatment
Experimental: Mephedrone
Mephedrone 200 mg, single dose, oral administration
Drug: Mephedrone
Single oral dose mephedrone
Other Names:
  • 4-methylmethcathinone
  • 4-MMC

Active Comparator: 3,4-methylenedioxymethamphetamine
3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration
Drug: 3,4-methylenedioxymethamphetamine
Single oral dose MDMA
Other Names:
  • MDMA
  • Ecstasy

Placebo Comparator: Lactose
Placebo, single dose, oral administration
Drug: Placebo
Single oal dose placebo
Other Name: Non active treatment




Primary Outcome Measures :
  1. Changes in blood pressure [ Time Frame: From pre-dose (baseline) to 4h post-dose ]
    Systolic and diastolic blood pressure


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Changes in heart rate [ Time Frame: From pre-dose (baseline) to 4h post-dose ]
    Measure of heart rate (pulse)

  6. 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

  7. Changes in oral temperature [ Time Frame: From pre-dose (baseline) to 4h post-dose ]
    Measure of temperature in mouth using automatic thermometer



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Spain
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Magi Farre, MD, PhD Parc de Salut Mar
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02232789    
Other Study ID Numbers: IMIMFTCL/MEF/1
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Parc de Salut Mar:
Mephedrone
3,4-methylenedioxymethamphetamine
Abuse liability
Human Pharmacology
Additional relevant MeSH terms:
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Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents