Substance UsePhase 1METI/FIS/1NCT05488171
Abuse Potential and Human Pharmacology of Methylone
A Phase 1 study testing Methylone and 3,4-methylenedioxymethamphetamine in people with Substance Use and Healthy Subjects, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Healthy Subjects
- What is being tested?
- Methylone and 3,4-methylenedioxymethamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 30 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Use, Healthy Subjects
- Being tested
- Methylone, 3,4-methylenedioxymethamphetamine, Placebo
- Keywords
- methylone, pharmacokinetics, acute effects, MDMA, abuse liability, human pharmacology
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethyloneDrug
Also called 3,4-methylenedioxy-N-methylcathinone, MDMC
Single oral dose of 200 mg of methylone.
3,4-methylenedioxymethamphetamineDrug
Also called MDMA, Ecstasy
Single oral dose of 100 mg of MDMA.
PlaceboDrug
Also called Non active treatment
Single oral dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Methylone | Experimental | Methylone (3,4-methylenedioxy-N-methylcathinone) 200 mg, single dose, oral administration Receives: Drug: Methylone |
| 3,4-methylenedioxymethamphetamine (MDMA) | Active comparator | MDMA (3,4-methylenedioxymethamphetamine) 100 mg, single dose, oral administration Receives: Drug: 3,4-methylenedioxymethamphetamine |
| Maltodextrin | Placebo comparator | Placebo, single dose, oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Differences from baseline to 24 hours after administration
Secondary outcomes (29)
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).
Measured: Differences from baseline to 24 hours after administration
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).
Measured: Differences from baseline to 24 hours after administration
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).
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours after administration
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.
Measured: Differences from baseline to 24 hours 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.
Measured: From baseline to 24 hours after methylone administration
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.
Measured: From baseline to 24 hours after MDMA administration
Time to reach maximum plasma concentration (Tmax) of methylone
Time (h) to reach maximum concentration of methylone in plasma after administration.
Measured: From baseline to 24 hours after methylone administration
Time to reach maximum plasma concentration (Tmax) of MDMA
Time (h) to reach maximum concentration of MDMA in plasma after administration.
Measured: From baseline to 24 hours after MDMA 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.
Measured: From baseline to 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.
Measured: From baseline to 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.
Measured: From baseline to 24 hours after methylone administration
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.
Measured: From baseline to 24 hours after MDMA administration
Time to reach maximum oral fluid concentration (Tmax) of methylone
Time (h) to reach maximum concentration of methylone in oral fluid after administration.
Measured: From baseline to 24 hours after methylone administration
Time to reach maximum oral fluid concentration (Tmax) of MDMA
Time (h) to reach maximum concentration of MDMA in oral fluid after administration.
Measured: From baseline to 24 hours after MDMA 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.
Measured: From baseline to 24 hours after methylone administration
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.
Measured: From baseline to 24 hours after MDMA administration
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.
Measured: From baseline to 24 hours 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.
Measured: From baseline to 24 hours 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.
Measured: From baseline to 12 hours after methylone administration
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.
Measured: From baseline to 12 hours after MDMA administration
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.
Measured: Only administered 8 hours 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.
Measured: Differences from baseline to 2 hours after administration
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.
Measured: Differences from baseline to 6 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Dec 2021
- Primary completion31 Jul 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Recerca Institut Germans Trias i Pujol, Istituto Superiore di Sanità
- Responsible party
- Sponsor
- Investigators
- Magi Farré, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488171
- Sponsor's protocol ID
- HUGTP/METI/FIS/1
- Acronym
- METI/FIS/1
- Status last verified
- Aug 2022
- First submitted
- 4 Feb 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poyatos L, Perez-Mana C, Hladun O, Nunez-Montero M, de la Rosa G, Martin S, Barriocanal AM, Carabias L, Kelmendi B, Taoussi O, Busardo FP, Fonseca F, Torrens M, Pichini S, Farre M, Papaseit E. Pharmacological effects of methylone and MDMA in humans. Front Pharmacol. 2023 Feb 17;14:1122861. doi: 10.3389/fphar.2023.1122861. eCollection 2023.
PubMed 36873994
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abuse Potential and Human Pharmacology of Methylone
- ClinicalTrials.gov ID
- NCT05488171
- Acronym / sponsor ID
- METI/FIS/1 / HUGTP/METI/FIS/1
- Conditions
- Substance Use, Healthy Subjects
- Keywords
- methylone, pharmacokinetics, acute effects, MDMA, abuse liability, human pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundació Recerca Institut Germans Trias i Pujol, Istituto Superiore di Sanità
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Methylone | Experimental | Drug: MethyloneMethylone (3,4-methylenedioxy-N-methylcathinone) 200 mg, single dose, oral administration |
| 3,4-methylenedioxymethamphetamine (MDMA) | Active comparator | Drug: 3,4-methylenedioxymethamphetamineMDMA (3,4-methylenedioxymethamphetamine) 100 mg, single dose, oral administration |
| Maltodextrin | Placebo comparator | Drug: PlaceboPlacebo, single dose, oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethyloneAlso: 3,4-methylenedioxy-N-methylcathinone, MDMCSingle oral dose of 200 mg of methylone. | Drug | Methylone |
| 3,4-methylenedioxymethamphetamineAlso: MDMA, EcstasySingle oral dose of 100 mg of MDMA. | Drug | 3,4-methylenedioxymethamphetamine (MDMA) |
| PlaceboAlso: Non active treatmentSingle oral dose of placebo. | Drug | Maltodextrin |
Primary outcome
Change in blood pressure: Emax (peak/maximum effects) in blood pressure
Time frame: Differences from baseline to 24 hours after administration
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.
29 secondary outcomes
Change in Heart rate: Emax (peak/maximum effects) in Heart rate
Time frame: Differences from baseline to 24 hours after administration
Change in Oral temperature: Emax (peak/maximum effects) in Oral temperature
Time frame: Differences from baseline to 24 hours after administration
Change in Pupil diameter: Emax (peak/maximum effects) in Pupil diameter
Time frame: Differences from baseline to 24 hours after administration
Change in Maddox Wing score (MW): Emax (peak/maximum effects)
Time frame: Differences from baseline to 24 hours after administration
Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects
Time frame: Differences from baseline to 24 hours after administration
Change in High: Emax (peak/maximum effects) in High feeling
Time frame: Differences from baseline to 24 hours after administration
Change in Stimulated: Emax (peak/maximum effects) in Stimulated feeling
Time frame: Differences from baseline to 24 hours after administration
Change in Liking: Emax (peak/maximum effects) in Liking feeling
Time frame: Differences from baseline to 24 hours after administration
Change in global drug effects assessed with ARCI: Emax (peak/maximum effects) in global drug effects
Time frame: Differences from baseline to 24 hours after administration
Change in global drug effects assessed with VESSPA: Emax (peak/maximum effects) in global drug effects
Time frame: Differences from baseline to 24 hours after administration
Maximum plasma concentration (Cmax) of methylone
Time frame: From baseline to 24 hours after methylone administration
Maximum plasma concentration (Cmax) of MDMA
Time frame: From baseline to 24 hours after MDMA administration
Time to reach maximum plasma concentration (Tmax) of methylone
Time frame: From baseline to 24 hours after methylone administration
Time to reach maximum plasma concentration (Tmax) of MDMA
Time frame: From baseline to 24 hours after MDMA administration
Area under the concentration-time curve (AUC 0-24 h) of methylone in plasma concentrations
Time frame: From baseline to 24 hours after methylone administration
Area under the concentration-time curve (AUC 0-24 h) of MDMA in plasma concentrations
Time frame: From baseline to 24 hours after MDMA administration
Maximum oral fluid concentration (Cmax) of methylone
Time frame: From baseline to 24 hours after methylone administration
Maximum oral fluid concentration (Cmax) of MDMA
Time frame: From baseline to 24 hours after MDMA administration
Time to reach maximum oral fluid concentration (Tmax) of methylone
Time frame: From baseline to 24 hours after methylone administration
Time to reach maximum oral fluid concentration (Tmax) of MDMA
Time frame: From baseline to 24 hours after MDMA administration
Area under the concentration-time curve (AUC 0-24h) of methylone oral fluid concentrations
Time frame: From baseline to 24 hours after methylone administration
Area under the concentration-time curve (AUC 0-24h) of MDMA oral fluid concentrations
Time frame: From baseline to 24 hours after MDMA administration
Total amount methylone excreted in 24 h urine samples.
Time frame: From baseline to 24 hours after methylone administration
Total amount MDMA excreted in 24 h urine samples.
Time frame: From baseline to 24 hours after MDMA administration
Total concentration of methylone present in sweat
Time frame: From baseline to 12 hours after methylone administration
Total concentration of MDMA present in sweat
Time frame: From baseline to 12 hours after MDMA administration
Pharmacological class identification
Time frame: Only administered 8 hours after administration
Change in psychomotor vigilance task (PVT): Emax (peak/maximum effects)
Time frame: Differences from baseline to 2 hours after administration
Psychiatric evaluation using Young Mania Rating Scale (YMRS)
Time frame: Differences from baseline to 6 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 36873994Poyatos L, Perez-Mana C, Hladun O, Nunez-Montero M, de la Rosa G, Martin S, Barriocanal AM, Carabias L, Kelmendi B, Taoussi O, Busardo FP, Fonseca F, Torrens M, Pichini S, Farre M, Papaseit E. Pharmacological effects of methylone and MDMA in humans. Front Pharmacol. 2023 Feb 17;14:1122861. doi: 10.3389/fphar.2023.1122861. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magi Farré, MD, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylone and 3,4-methylenedioxymethamphetamine in people with Substance Use and Healthy Subjects, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure: Emax (peak/maximum effects) in blood pressure (time frame: Differences from baseline to 24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.