DrugLib.com — Drug Information Portal

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



Mephedrone and Alcohol Interactions in Humans

Information source: Parc de Salut Mar
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amphetamine-Related Disorders; Alcohol-Related Disorders

Intervention: Mephedrone and alcohol (Drug); Mephedrone (Drug); Alcohol (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Parc de Salut Mar

Official(s) and/or principal investigator(s):
Magí Farré, MD, PhD, Principal Investigator, Affiliation: Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc

Overall contact:
Magí Farré, MD, PhD, Phone: +34 93 3160490, Ext: 1490, Email: mfarre@imim.es

Summary

The purposes of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.

Clinical Details

Official title: Mephedrone and Alcohol Interactions After Single-dose Administration in Humans

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

Primary outcome: Change in drunkenness and drowsiness and effects

Secondary outcome:

Change in other subjective effects

Change in blood pressure

Change in psychomotor function

Change in memory function

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

Area Under the Concentration-Time Curve (AUC 0-10h)

Number of Participants with Serious and Non-Serious Adverse Events

Elimination hal-life

Elimination hal-life

Change in heart rate

Change in pupil diameter

Change in oral temperature

Detailed description: Mephedrone (4-methylmetcathinone, 4-MMC) is a new psychoactive substance (NPS). Mephedrone is frequently used in combination with alcohol. At present, the effects of the interaction between mephedrone and alcohol in humans have not been previously evaluated in randomized controlled clinical trials. The aims of this study are 1) to evaluate the pharmacological effects after oral coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.

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 derivate, mephedrone or

other cathinone on at least 6 occasions (two in the previous year) without any adverse reactions.

- Recreational use of alcohol (ethanol). Previous experience in acute alcohol

intoxication.

- 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:

- Not meeting the inclusion 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). 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 derivate, 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

Magí Farré, MD, PhD, Phone: +34 93 3160490, Ext: 1490, Email: mfarre@imim.es

Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar., Barcelona 08003, Spain; Recruiting
Magí Farré, MD, PhD, Phone: +34 933160490, Ext: 1490, Email: mfarre@imim.es
Esther Papaseit, MD, Phone: +34 933160494, Ext: 1494, Email: epapaseit@imim.es
Esther Papaseit, MD, Sub-Investigator
Clara Perez-Maña, MD, PhD, Sub-Investigator
Julian Mateus, MD, Sub-Investigator
Rafael de la Torre, PharmD, Sub-Investigator
Francina Fonseca, MD, Sub-Investigator
Elizabeth de Sousa Fernandes, Bsc, Sub-Investigator
Additional Information

Starting date: November 2014
Last updated: November 28, 2014

Page last updated: August 23, 2015

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

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