Abuse Liability and Human Pharmacology of Mephedrone

December 3, 2014 updated by: Parc de Salut Mar

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Non active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood pressure
Time Frame: From pre-dose (baseline) to 4h post-dose
Systolic and diastolic blood pressure
From pre-dose (baseline) to 4h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-dose (baseline) to 4h post-dose
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.
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
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
7 days after each substance administration
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.
From baseline to 24h post-dose
Changes in heart rate
Time Frame: From pre-dose (baseline) to 4h post-dose
Measure of heart rate (pulse)
From pre-dose (baseline) to 4h post-dose
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
From pre-dose (baseline) to 4h post-dose
Changes in oral temperature
Time Frame: From pre-dose (baseline) to 4h post-dose
Measure of temperature in mouth using automatic thermometer
From pre-dose (baseline) to 4h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Magí Farré, MD, PhD, Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIMFTCL/MEF/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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