Back to resultsAbuse Potential and Human Pharmacology of Methylone (METI/FIS/1)
Primary Purpose
Substance Use, Healthy Subjects
Status
Active
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Methylone
3,4-methylenedioxymethamphetamine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Substance Use focused on measuring methylone, pharmacokinetics, acute effects, MDMA, abuse liability, human pharmacology
Eligibility Criteria
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.
Sites / Locations
- Germans Trias i Pujol Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Methylone
3,4-methylenedioxymethamphetamine (MDMA)
Maltodextrin
Arm Description
Methylone (3,4-methylenedioxy-N-methylcathinone) 200 mg, single dose, oral administration
MDMA (3,4-methylenedioxymethamphetamine) 100 mg, single dose, oral administration
Placebo, single dose, oral administration
Outcomes
Primary Outcome Measures
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Non-invasive systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) were repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Blood pressure measured in mmHg.
Secondary Outcome Measures
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Heart rate was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Heart rate measured in beats per minute (bpm).
Change in Oral temperature: Emax (peak/maximum effects) in Oral temperature
Oral temperature was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Oral temperature measured in Celsius degrees (ºC).
Change in Pupil diameter: Emax (peak/maximum effects) in Pupil diameter
Pupil diameter was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Pupil diameter measured in millimeters (mm).
Change in Maddox Wing score (MW): Emax (peak/maximum effects)
Maddox wing is a device that measures the balance of extraocular muscles and quantifies exophoria as an indicator of extraocular muscle relaxation. From 22 (exophoria) to 15 (esophoria).
It is measured at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h.
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Intensity of effects will be measured using a visual analog scale (0-100 mm) at baseline (h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more intensity of effects.
Change in High: Emax (peak/maximum effects) in High feeling
High will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more high feeling.
Change in Stimulated: Emax (peak/maximum effects) in Stimulated feeling
Stimulation will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more stimulation.
Change in Liking: Emax (peak/maximum effects) in Liking feeling
Liking will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more liking.
Change in global drug effects assessed with ARCI: Emax (peak/maximum effects) in global drug effects
Global drug effects will be measured using the short form (49 items) of the Addiction Research Center Inventory (ARCI). This is a true/false response questionnaire with 49 items. The global results include five subscales (sedation, euphoria, dysphoria, intellectual efficiency and amphetamine-like effects.
It is administered at baseline and 1, 2, 3, 4, 6, 8, and 10 h after administration.
Scores range usually from a total of 12 to 57 points. More points mean more effects.
Change in global drug effects assessed with VESSPA: Emax (peak/maximum effects) in global drug effects
Global drug effects will be measured using the Evaluation of the Subjective Effects of Substances with Abuse Potential questionnaire (VESSPA-SSE). This questionnaire consists of 36 items (0-4 score) that evaluate subjective effects related to stimulants such as MDMA. VESSPA includes six subscales (sedation, psychosomatic anxiety, changes in perception, pleasure and sociability, activity and energy, and psychotic symptoms). Scores of each subscale ranges from 0 to 24 (maximal effects)
It is administered at baseline and 1, 2, 3, 4, 6, 8, and 10 h after administration.
Maximum plasma concentration (Cmax) of methylone
Calculation of maximum concentration of methylone (ng/mL) in samples collected from 15 min prior to administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Maximum plasma concentration (Cmax) of MDMA
Calculation of maximum concentration of MDMA (ng/mL) in samples collected from 15 min prior to administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time to reach maximum plasma concentration (Tmax) of methylone
Time (h) to reach maximum concentration of methylone in plasma after administration.
Time to reach maximum plasma concentration (Tmax) of MDMA
Time (h) to reach maximum concentration of MDMA in plasma after administration.
Area under the concentration-time curve (AUC 0-24 h) of methylone in plasma concentrations
Calculation of AUC with samples collected from 15 min prior (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours after methylone administration.
Area under the concentration-time curve (AUC 0-24 h) of MDMA in plasma concentrations
Calculation of AUC with samples collected from 15 min prior (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours after MDMA administration.
Maximum oral fluid concentration (Cmax) of methylone
Calculation of maximum concentration (ng/mL) of methylone in oral fluid (saliva) samples collected with a Salivette device at the same time points as serum. Oral fluid is collected 15 min before administration (time 0), at to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Maximum oral fluid concentration (Cmax) of MDMA
Calculation of maximum concentration (ng/mL) of MDMA in oral fluid (saliva) samples collected with a Salivette device at the same time points as serum. Oral fluid is collected 15 min before administration (time 0), at to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time to reach maximum oral fluid concentration (Tmax) of methylone
Time (h) to reach maximum concentration of methylone in oral fluid after administration.
Time to reach maximum oral fluid concentration (Tmax) of MDMA
Time (h) to reach maximum concentration of MDMA in oral fluid after administration.
Area under the concentration-time curve (AUC 0-24h) of methylone oral fluid concentrations
Calculation of AUC with oral fluid samples collected from 15 min prior to methylone administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Area under the concentration-time curve (AUC 0-24h) of MDMA oral fluid concentrations
Calculation of AUC with oral fluid samples collected from 15 min prior to MDMA administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Total amount methylone excreted in 24 h urine samples.
Urine was collected 15 minutes before administration (time 0) and then between 0-4 h, 4-8 h, 8-12 h, and 12-24 h after methylone administration.
Total amount MDMA excreted in 24 h urine samples.
Urine was collected 15 minutes before administration (time 0) and then between 0-4 h, 4-8 h, 8-12 h, and 12-24 h after MDMA administration.
Total concentration of methylone present in sweat
Concentration of methylone in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 0-4 h, 0-6 h, 0-8 h, and 0-10 h, 10-12 h.
Total concentration of MDMA present in sweat
Concentration of MDMA in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 0-4 h, 0-6 h, 0-8 h, and 0-10 h, 10-12 h.
Pharmacological class identification
In the pharmacological class identification questionnaire, the participant selects the pharmacological class that better describes the administered drug.
This questionnaire is administered 8 h after administration.
Change in psychomotor vigilance task (PVT): Emax (peak/maximum effects)
Test will be performed using specific computer software that assesses simple reaction time to a numeric stimulus. Results are milliseconds (increased simple reaction time is related to worst psychomotor performance) It is measured at baseline (45 and 30 min) prior to administration, and at 1 and 2 h.
Psychiatric evaluation using Young Mania Rating Scale (YMRS)
YMRS (11 items) assessing manic symptoms from 0 to 4 (total score from 0 to 44).
It is measured at baseline (30 min) prior to administration, and at 0.5, 1, 4, and 6 h after administration.
A higher score indicates a higher severity of mania.
Full Information
NCT ID
NCT05488171
First Posted
February 4, 2022
Last Updated
August 4, 2022
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Recerca Institut Germans Trias i Pujol, Istituto Superiore di Sanità
1. Study Identification
Unique Protocol Identification Number
NCT05488171
Brief Title
Abuse Potential and Human Pharmacology of Methylone
Acronym
METI/FIS/1
Official Title
Abuse Potential and Human Pharmacology of Methylone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Recerca Institut Germans Trias i Pujol, Istituto Superiore di Sanità
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Methylone is a synthetic cathinone that has been popularized as an alternative to other illegal psychostimulants as methylenedioxymethamphetamine (MDMA, ecstasy) or mephedrone. Chemically, methylone is a beta-keto analogue of ecstasy with similar pharmacological effects in animals. To date, the available data about the human pharmacology of methylone in humans is very scarce and is mainly provided by users' experience published in internet forums or intoxication reports.
A pilot study was carried out to select the methylone dose used in this study. This current study is aimed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Healthy Subjects
Keywords
methylone, pharmacokinetics, acute effects, MDMA, abuse liability, human pharmacology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
The protocol comprises a pilot study (n= 12) and a definitive study (n=17, 14 men and 3 women).
The pilot study was a phase I dose-finding study that included 4 cohorts of 3 subjects (cohort 1,2,3 and 5). The conditions of each cohort were: 50 and 100 mg of methylone and placebo in cohort 1 (n= 3); 100 and 150 mg of methylone and placebo in cohort 2 (n= 3); 150 and 200 mg of methylone and placebo in cohort 3 (n= 3); 200 mg of methylone, 100 mg of MDMA and placebo in cohort 5 (n= 3). For safety reasons in cohorts 1-2-3, lower doses were allocated before the higher doses.
After completion, the pilot study allowed defining the treatment conditions and interventions of the definitive study. The present definitive study was designed as double-blind, placebo-controlled, crossover and randomized. Each subject will participate in three experimental sessions, in each one treatment will be administered. Study treatment conditions are 200 mg of methylone, 100 mg of MDMA and placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Identical white hard gelatin capsules
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylone
Arm Type
Experimental
Arm Description
Methylone (3,4-methylenedioxy-N-methylcathinone) 200 mg, single dose, oral administration
Arm Title
3,4-methylenedioxymethamphetamine (MDMA)
Arm Type
Active Comparator
Arm Description
MDMA (3,4-methylenedioxymethamphetamine) 100 mg, single dose, oral administration
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Placebo, single dose, oral administration
Intervention Type
Drug
Intervention Name(s)
Methylone
Other Intervention Name(s)
3,4-methylenedioxy-N-methylcathinone, MDMC
Intervention Description
Single oral dose of 200 mg of methylone.
Intervention Type
Drug
Intervention Name(s)
3,4-methylenedioxymethamphetamine
Other Intervention Name(s)
MDMA, Ecstasy
Intervention Description
Single oral dose of 100 mg of MDMA.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Non active treatment
Intervention Description
Single oral dose of placebo.
Primary Outcome Measure Information:
Title
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Description
Non-invasive systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) were repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Blood pressure measured in mmHg.
Time Frame
Differences from baseline to 24 hours after administration
Secondary Outcome Measure Information:
Title
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Description
Heart rate was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Heart rate measured in beats per minute (bpm).
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Oral temperature: Emax (peak/maximum effects) in Oral temperature
Description
Oral temperature was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Oral temperature measured in Celsius degrees (ºC).
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Pupil diameter: Emax (peak/maximum effects) in Pupil diameter
Description
Pupil diameter was repeatedly recorded at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Pupil diameter measured in millimeters (mm).
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Maddox Wing score (MW): Emax (peak/maximum effects)
Description
Maddox wing is a device that measures the balance of extraocular muscles and quantifies exophoria as an indicator of extraocular muscle relaxation. From 22 (exophoria) to 15 (esophoria).
It is measured at baseline (45 and 30 min) prior to administration, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Description
Intensity of effects will be measured using a visual analog scale (0-100 mm) at baseline (h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more intensity of effects.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in High: Emax (peak/maximum effects) in High feeling
Description
High will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more high feeling.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Stimulated: Emax (peak/maximum effects) in Stimulated feeling
Description
Stimulation will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more stimulation.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in Liking: Emax (peak/maximum effects) in Liking feeling
Description
Liking will be measured using a visual analog scale (0-100 mm) at baseline and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h after administration.
Higher mm means more liking.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in global drug effects assessed with ARCI: Emax (peak/maximum effects) in global drug effects
Description
Global drug effects will be measured using the short form (49 items) of the Addiction Research Center Inventory (ARCI). This is a true/false response questionnaire with 49 items. The global results include five subscales (sedation, euphoria, dysphoria, intellectual efficiency and amphetamine-like effects.
It is administered at baseline and 1, 2, 3, 4, 6, 8, and 10 h after administration.
Scores range usually from a total of 12 to 57 points. More points mean more effects.
Time Frame
Differences from baseline to 24 hours after administration
Title
Change in global drug effects assessed with VESSPA: Emax (peak/maximum effects) in global drug effects
Description
Global drug effects will be measured using the Evaluation of the Subjective Effects of Substances with Abuse Potential questionnaire (VESSPA-SSE). This questionnaire consists of 36 items (0-4 score) that evaluate subjective effects related to stimulants such as MDMA. VESSPA includes six subscales (sedation, psychosomatic anxiety, changes in perception, pleasure and sociability, activity and energy, and psychotic symptoms). Scores of each subscale ranges from 0 to 24 (maximal effects)
It is administered at baseline and 1, 2, 3, 4, 6, 8, and 10 h after administration.
Time Frame
Differences from baseline to 24 hours after administration
Title
Maximum plasma concentration (Cmax) of methylone
Description
Calculation of maximum concentration of methylone (ng/mL) in samples collected from 15 min prior to administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after methylone administration
Title
Maximum plasma concentration (Cmax) of MDMA
Description
Calculation of maximum concentration of MDMA (ng/mL) in samples collected from 15 min prior to administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Time to reach maximum plasma concentration (Tmax) of methylone
Description
Time (h) to reach maximum concentration of methylone in plasma after administration.
Time Frame
From baseline to 24 hours after methylone administration
Title
Time to reach maximum plasma concentration (Tmax) of MDMA
Description
Time (h) to reach maximum concentration of MDMA in plasma after administration.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Area under the concentration-time curve (AUC 0-24 h) of methylone in plasma concentrations
Description
Calculation of AUC with samples collected from 15 min prior (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours after methylone administration.
Time Frame
From baseline to 24 hours after methylone administration
Title
Area under the concentration-time curve (AUC 0-24 h) of MDMA in plasma concentrations
Description
Calculation of AUC with samples collected from 15 min prior (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours after MDMA administration.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Maximum oral fluid concentration (Cmax) of methylone
Description
Calculation of maximum concentration (ng/mL) of methylone in oral fluid (saliva) samples collected with a Salivette device at the same time points as serum. Oral fluid is collected 15 min before administration (time 0), at to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after methylone administration
Title
Maximum oral fluid concentration (Cmax) of MDMA
Description
Calculation of maximum concentration (ng/mL) of MDMA in oral fluid (saliva) samples collected with a Salivette device at the same time points as serum. Oral fluid is collected 15 min before administration (time 0), at to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Time to reach maximum oral fluid concentration (Tmax) of methylone
Description
Time (h) to reach maximum concentration of methylone in oral fluid after administration.
Time Frame
From baseline to 24 hours after methylone administration
Title
Time to reach maximum oral fluid concentration (Tmax) of MDMA
Description
Time (h) to reach maximum concentration of MDMA in oral fluid after administration.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Area under the concentration-time curve (AUC 0-24h) of methylone oral fluid concentrations
Description
Calculation of AUC with oral fluid samples collected from 15 min prior to methylone administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after methylone administration
Title
Area under the concentration-time curve (AUC 0-24h) of MDMA oral fluid concentrations
Description
Calculation of AUC with oral fluid samples collected from 15 min prior to MDMA administration (time 0) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Total amount methylone excreted in 24 h urine samples.
Description
Urine was collected 15 minutes before administration (time 0) and then between 0-4 h, 4-8 h, 8-12 h, and 12-24 h after methylone administration.
Time Frame
From baseline to 24 hours after methylone administration
Title
Total amount MDMA excreted in 24 h urine samples.
Description
Urine was collected 15 minutes before administration (time 0) and then between 0-4 h, 4-8 h, 8-12 h, and 12-24 h after MDMA administration.
Time Frame
From baseline to 24 hours after MDMA administration
Title
Total concentration of methylone present in sweat
Description
Concentration of methylone in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 0-4 h, 0-6 h, 0-8 h, and 0-10 h, 10-12 h.
Time Frame
From baseline to 12 hours after methylone administration
Title
Total concentration of MDMA present in sweat
Description
Concentration of MDMA in ng/patch. Samples were collected with dermal patches (5 x 5 cm areas) applied to the back and removed at different intervals such as: 0-2 h, 0-4 h, 0-6 h, 0-8 h, and 0-10 h, 10-12 h.
Time Frame
From baseline to 12 hours after MDMA administration
Title
Pharmacological class identification
Description
In the pharmacological class identification questionnaire, the participant selects the pharmacological class that better describes the administered drug.
This questionnaire is administered 8 h after administration.
Time Frame
Only administered 8 hours after administration
Title
Change in psychomotor vigilance task (PVT): Emax (peak/maximum effects)
Description
Test will be performed using specific computer software that assesses simple reaction time to a numeric stimulus. Results are milliseconds (increased simple reaction time is related to worst psychomotor performance) It is measured at baseline (45 and 30 min) prior to administration, and at 1 and 2 h.
Time Frame
Differences from baseline to 2 hours after administration
Title
Psychiatric evaluation using Young Mania Rating Scale (YMRS)
Description
YMRS (11 items) assessing manic symptoms from 0 to 4 (total score from 0 to 44).
It is measured at baseline (30 min) prior to administration, and at 0.5, 1, 4, and 6 h after administration.
A higher score indicates a higher severity of mania.
Time Frame
Differences from baseline to 6 hours after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magi Farré, MD, PhD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Abuse Potential and Human Pharmacology of Methylone
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