Mephedrone and Alcohol Interactions in Humans

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2015
• Main ID: NCT02294266
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: Parc de Salut Mar
• Public title: Mephedrone and Alcohol Interactions in Humans
• Scientific title: Mephedrone and Alcohol Interactions After Single-dose Administration in Humans
• Date of first enrolment: December 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02294266
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: Phase 1

Countries of recruitment

Spain

Contacts

• Name: Magí Farré, MD, PhD
• Affiliation: Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Alcohol-Related Disorders

Amphetamine-Related Disorders

Intervention(s)

Drug: Mephedrone

Drug: Mephedrone and alcohol

Drug: Alcohol

Drug: Placebo

Primary Outcome(s)

Change in drunkenness and drowsiness and effects [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Secondary Outcome(s)

Change in blood pressure [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Change in other subjective effects [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Elimination hal-life [Time Frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, an 10h post-dose]

Change in oral temperature [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Elimination hal-life [Time Frame: 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]

Area Under the Concentration-Time Curve (AUC 0-24h) [Time Frame: From pre-dose (baseline, 0h) to 0.15, 0.3, 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose]

Number of Participants with Serious and Non-Serious Adverse Events [Time Frame: 7 days after each]

Change in heart rate [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Change in psychomotor function [Time Frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose]

Change in pupil diameter [Time Frame: From pre-dose (baseline, 0h) to 6h post-dose]

Area Under the Concentration-Time Curve (AUC 0-10h) [Time Frame: From pre-dose (baseline, 0h) to 0.45, 1, 1.5, 2, 3, 4, 6, 8, and 10h post-dose]

Change in memory function [Time Frame: From pre-dose (baseline, 0h) to 1, 1.5 and 4h post-dose]

Secondary ID(s)

IMIMFTCL/MEF/2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Salud Carlos III