DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Abuse Liability and Human Pharmacology of Mephedrone

Information source: Parc de Salut Mar
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amphetamine-Related Disorders

Intervention: Mephedrone (Drug); 3,4-methylenedioxymethamphetamine (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Parc de Salut Mar

Official(s) and/or principal investigator(s):
Magi Farre, MD, PhD, Principal Investigator, Affiliation: Parc de Salut Mar

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).

Clinical Details

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

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

Primary outcome: Changes in blood pressure

Secondary outcome:

Changes in euphoria-good effects

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

Number of Participants with Serious and Non-Serious Adverse Events

Elimination half-life

Changes in heart rate

Changes in pupil diameter

Changes in oral temperature

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).

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

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

Starting date: September 2014
Last updated: December 3, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017