Abuse Liability and Human Pharmacology of Mephedrone

NCT02232789 | Completed Phase 1 DMC

• 1 other identifier: IMIMFTCL/MEF/1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Amphetamine-Related Disorders

Keywords

Mephedrone; 3,4-methylenedioxymethamphetamine; Abuse liability; Human Pharmacology

Outcome Measures

Primary Outcomes (1)

• Changes in blood pressure

  Systolic and diastolic blood pressure

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

Secondary Outcomes (7)

• Changes in euphoria-good effects

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

• Area Under the Concentration-Time Curve (AUC 0-24h)

  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

  7 days after each substance administration

• Elimination half-life

  From baseline to 24h post-dose

• Changes in heart rate

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

Study Arms (3)

Mephedrone

EXPERIMENTAL

Mephedrone 200 mg, single dose, oral administration

Drug: Mephedrone

3,4-methylenedioxymethamphetamine

ACTIVE COMPARATOR

3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration

Drug: 3,4-methylenedioxymethamphetamine

Lactose

PLACEBO COMPARATOR

Placebo, single dose, oral administration

Drug: Placebo

Interventions

Mephedrone DRUG

Single oral dose mephedrone

Also known as: 4-methylmethcathinone, 4-MMC

Mephedrone

3,4-methylenedioxymethamphetamine DRUG

Single oral dose MDMA

Also known as: MDMA, Ecstasy

3,4-methylenedioxymethamphetamine

Placebo DRUG

Single oal dose placebo

Also known as: Non active treatment

Lactose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Daily consumption \>20 cigarettes and \>4 standard units of ethanol.
• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

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

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

• Papaseit E, Perez-Mana C, Mateus JA, Pujadas M, Fonseca F, Torrens M, Olesti E, de la Torre R, Farre 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.

  PMID: 27206266 DERIVED

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

mephedrone; N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Magi Farre, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

ES (1)