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Unknown statusPhase 1

Abuse Potential and Human Pharmacology of Methylone

NCT05488171 · METI/FIS/1 · Germans Trias i Pujol Hospital

Closed to entry
Status
Not accepting participants
Phase 1
Phase
17
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The purposes of the study are 1) To assess the abuse potential of methylone after controlled administration of a single oral dose of methylone 2) to evaluate subjective and physiological effects of methylone 3) to determine the pharmacokinetics parameters and metabolism of methylone.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in blood pressure: Emax (peak/maximum effects) in blood pressure

    Measured over Differences from baseline to 24 hours after administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Understanding and accepting all the study procedures and signing the informed consent. * Healthy male and female volunteers aged between 18 and 45. * Clinical history and physical examination demonstrating no organic or psychiatric disorders. * The electrocardiogram and general blood and urine laboratory tests performed before the study must 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. * Body weight between 50 and 90 kg and body mass index (BMI) between 19-27 kg/m². In case of women, they must weight at least 55 kg to participate. Lower or higher weights and/or BMIs will be accepted if the researchers consider that do not pose a risk to the subjects and do not interfere with the objectives of the study. * Recreational use of methylone or other synthetic cathinones, amphetamines and/or ecstasy at least 6 occasions (two in the previous year) without serious adverse reactions. * Women who have regular 26-32 day menstrual cycles (maximum 35 days). Participation only in follicular phase of menstrual cycle. * Participants who agree to use reliable methods of contraception during the study such as abstinence, intrauterine devices, barrier methods with or without spermicide, or who have a vasectomized partner. Exclusion Criteria: * Present history of a substance use disorder according to Diagnostic and Statistical Manual for Mental Disorders (DSM-V), except for nicotine. Past history of mild substance use disorder (corresponding to substance abuse according to DSM-IV) could be included. * Having had any somatic disease or having undergone major surgery in the 3 months prior to inclusion in the trial. * Individual psychiatric history or schizophrenia in first-degree relatives. * Previous or actual psychiatric disorders, alcoholism, abuse of prescription drugs or illegal substances or regular consumption of psychoactive drugs. * Daily consumption of \>40 grams of alcohol and/or \>20 cigarettes. * Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks. In the exceptional case of having participated in this study, there is a washout period of 2 months. * History of allergy or serious adverse reactions to medications and/or drugs. * Pathological history or evidence of a preexisting condition (including gastrointestinal, liver, or kidney disorders) that may alter the absorption, distribution, metabolism or excretion of drugs or symptoms suggestive of drug-induced gastrointestinal irritation. * 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. * Having taken medication regularly in the month prior to the study sessions, excepting vitamins, herbal remedies or dietary supplements that, according to the researchers, do not pose a risk to the subjects and do not interfere in the objectives of the study. Single doses of symptomatic medication in the week prior to experimental sessions will be admitted if it is assumed that blood concentrations have been eliminated on the day of the experimental session. * Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner). * Women with amenorrhea or severe premenstrual syndrome.

Where

1 study site

FacilityCityRegionCountry
Germans Trias i Pujol HospitalBadalonaBarcelonaSpain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05488171 on ClinicalTrials.gov →

Last updated in the registry 2022-08-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication