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CompletedPhase 1

Abuse Liability and Human Pharmacology of Mephedrone

NCT02232789 · Parc de Salut Mar

Closed to entry
Status
Not accepting participants
Phase 1
Phase
12
Target enrolment
1
Study sites
Outside the US

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in blood pressure

    Measured over From pre-dose (baseline) to 4h post-dose

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
MALE
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.BarcelonaBarcelonaSpain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02232789 on ClinicalTrials.gov →

Last updated in the registry 2014-12-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits