Mephedrone and Alcohol Interactions in Humans

Alcohol-Related Disorders Clinical Trial

Official title:

Mephedrone and Alcohol Interactions After Single-dose Administration in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294266
• Other study ID #: IMIMFTCL/MEF/2
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2014
• Last updated: October 7, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• 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 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.

Study Design

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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Amphetamine-Related Disorders
• Disease

Intervention

Drug:
• Mephedrone and alcohol
Single oral dose mephedrone Single oral dose alcohol
• Mephedrone
Single oral dose mephedrone
• Alcohol
Single oral dose alcohol
• Placebo
Single oral 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	Change in drunkenness and drowsiness and effects	Drunkenness and drowsiness effects will be measured using rate scales (visual analogue scales).	From pre-dose (baseline, 0h) to 6h post-dose	No
Secondary	Change in other subjective effects	Subjective effects will be measured using rate 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 and alcohol.	From pre-dose (baseline, 0h) to 6h post-dose	No
Secondary	Change in blood pressure	Systolic and diastolic blood pressure	From pre-dose (baseline, 0h) to 6h post-dose	No
Secondary	Change in psychomotor function	Psychomotor function will be measured using Critical tracking task (CTT) and Divided Attention Task (DAT).	From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose	No
Secondary	Change in memory function	Memory function will be measured using Spatial Memory Task (SMT).	From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose	No
Secondary	Area Under the Concentration-Time Curve (AUC 0-24h)	Calculation of AUC of the concentrations of mephedrone and its metabolites in blood and urine.	From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose	No
Secondary	Area Under the Concentration-Time Curve (AUC 0-10h)	Calculation of AUC of the concentrations of alcohol in blood.	From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h 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	Yes
Secondary	Elimination hal-life	Calculation of elimination hal-life from concentrations of mephedrone and its metabolites in blood and urine.	From pre-dose (baseline, 0h) to 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24h post-dose	No
Secondary	Elimination hal-life	Calculation of elimination hal-life from concentrations of alcohol in blood.	From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose	No
Secondary	Change in heart rate	Measure of heart rate	From pre-dose (baseline, 0h) to 6h post-dose	No
Secondary	Change in pupil diameter	Measure of pupil diameter	From pre-dose (baseline, 0h) to 6h post-dose	No
Secondary	Change in oral temperature	Measure of oral temperature	From pre-dose (baseline, 0h) to 6h post-dose	No