Abuse Liability and Human Pharmacology of Mephedrone

Amphetamine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232789
• Other study ID #: IMIMFTCL/MEF/1
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2014
• Last updated: December 3, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

Intervention

Drug:
• Mephedrone
Single oral dose mephedrone
• 3,4-methylenedioxymethamphetamine
Single oral dose MDMA
• Placebo
Single oal dose placebo

Locations

Country	Name	City	State
Spain	Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood pressure	Systolic and diastolic blood pressure	From pre-dose (baseline) to 4h post-dose	No
Secondary	Changes in euphoria-good effects	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	No
Secondary	Area Under the Concentration-Time Curve (AUC 0-24h)	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	No
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators	7 days after each substance administration	Yes
Secondary	Elimination half-life	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	No
Secondary	Changes in heart rate	Measure of heart rate (pulse)	From pre-dose (baseline) to 4h post-dose	No
Secondary	Changes in pupil diameter	Measure of pupil diameter and capacity of convergence (esophoria) using a pupillometer	From pre-dose (baseline) to 4h post-dose	No
Secondary	Changes in oral temperature	Measure of temperature in mouth using automatic thermometer	From pre-dose (baseline) to 4h post-dose	No