NCT02294266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

November 17, 2014

Last Update Submit

October 7, 2015

Conditions

Amphetamine-Related DisordersAlcohol-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (12)

  • Change in other subjective effects

    From pre-dose (baseline, 0h) to 6h post-dose

  • Change in blood pressure

    From pre-dose (baseline, 0h) to 6h post-dose

  • Change in psychomotor function

    From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose

  • Change in memory function

    From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose

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

    From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose

  • +7 more secondary outcomes

Study Arms (4)

Mephedrone and alcohol

EXPERIMENTAL

Mephedrone 200 mg, single dose, oral administration Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration

Drug: Mephedrone and alcohol

Mephedrone

ACTIVE COMPARATOR

Mephedrone 200 mg, single dose, oral administration Lemon-flavoured water (350 ml), single dose, oral administration

Drug: Mephedrone

Alcohol

ACTIVE COMPARATOR

Lactose 200 mg, single dose, oral administration Alcohol 0.8g/kg diluted in lemon-flavoured water (350 ml), single dose, oral administration

Drug: Alcohol

Placebo

PLACEBO COMPARATOR

Lactose 200 mg, single dose, oral administration Lemon-flavoured water (350 ml), single dose, oral administration

Drug: Placebo

Interventions

Mephedrone and alcoholDRUG

Single oral dose mephedrone Single oral dose alcohol

Also known as: 4-methylmetcathinone; 4-MMC, Alcohol
Mephedrone and alcohol
MephedroneDRUG

Single oral dose mephedrone

Also known as: 4-methylmetcathinone; 4-MMC
Mephedrone
AlcoholDRUG

Single oral dose alcohol

Alcohol
PlaceboDRUG

Single oral dose placebo

Also known as: Non-active treatment
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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 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.

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). 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, 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.

    PMID: 32063845DERIVED

MeSH Terms

Conditions

Amphetamine-Related DisordersAlcohol-Related Disorders

Interventions

mephedroneEthanol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Magí Farré, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 19, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

ES(1)