Mephedrone and Alcohol Interactions in Humans

NCT ID: NCT02294266

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-03-31

Brief 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.

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.

Conditions

Amphetamine-Related Disorders; Alcohol-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

Mephedrone and alcohol

Mephedrone 200 mg, single dose, oral administration

Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration

Group Type: EXPERIMENTAL

Mephedrone and alcohol

Intervention Type: DRUG

Single oral dose mephedrone

Single oral dose alcohol

Mephedrone

Mephedrone 200 mg, single dose, oral administration

Lemon-flavoured water (350 ml), single dose, oral administration

Group Type: ACTIVE_COMPARATOR

Mephedrone

Intervention Type: DRUG

Single oral dose mephedrone

Alcohol

Lactose 200 mg, single dose, oral administration

Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration

Group Type: ACTIVE_COMPARATOR

Alcohol

Intervention Type: DRUG

Single oral dose alcohol

Placebo

Lactose 200 mg, single dose, oral administration

Lemon-flavoured water (350 ml), single dose, oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single oral dose placebo

Interventions

Mephedrone and alcohol

Single oral dose mephedrone

Single oral dose alcohol

Intervention Type: DRUG

Mephedrone

Single oral dose mephedrone

Intervention Type: DRUG

Alcohol

Single oral dose alcohol

Intervention Type: DRUG

Placebo

Single oral dose placebo

Intervention Type: DRUG

Other Intervention Names

4-methylmetcathinone; 4-MMC; Alcohol; 4-methylmetcathinone; 4-MMC; Non-active treatment

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magí Farré, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Barcelona, Barcelona, Spain

Countries

Spain

References

Papaseit E, Perez-Mana C, de Sousa Fernandes Perna EB, Olesti E, Mateus J, Kuypers KP, Theunissen EL, Fonseca F, Torrens M, Ramaekers JG, de la Torre R, Farre M. Mephedrone and Alcohol Interactions in Humans. Front Pharmacol. 2020 Jan 28;10:1588. doi: 10.3389/fphar.2019.01588. eCollection 2019.

Reference Type: DERIVED

PMID: 32063845 (View on PubMed)

Other Identifiers

IMIMFTCL/MEF/2

Identifier Type: -

Identifier Source: org_study_id