Amphetamine-Related DisordersPhase 1NCT02232789
Abuse Liability and Human Pharmacology of Mephedrone
A Phase 1 study testing Mephedrone and 3,4-methylenedioxymethamphetamine in people with Amphetamine-Related Disorders, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Mephedrone 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
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 derivatives, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without serious adverse reactions.
- 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.
Who cannot join
- 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). Subjects with 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.
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- 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 derivatives, 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar.
Barcelona, Barcelona, 08003
About this study
Official title: Abuse Liability and Human Pharmacology of Mephedrone (4-methylmethcathinone,4-MMC)
The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
Read the detailed description
Mephedrone is a new psychoactive substance (NPS). At present, there are no randomized controlled trials evaluating the effects of mephedrone in humans. The current body of knowledge regarding the acute effects of mephedrone is based on anecdotal, self-reported effects (e.g. internet forums), case reports, and emergency room series and fatalities.
The aims of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Mephedrone, 3,4-methylenedioxymethamphetamine, Placebo
- Keywords
- Mephedrone, 3,4-methylenedioxymethamphetamine, Abuse liability, Human Pharmacology
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MephedroneDrug
Also called 4-methylmethcathinone, 4-MMC
Single oral dose mephedrone
3,4-methylenedioxymethamphetamineDrug
Also called MDMA, Ecstasy
Single oral dose MDMA
PlaceboDrug
Also called Non active treatment
Single oal dose placebo
| Study group | Role | What they receive |
|---|---|---|
| Mephedrone | Experimental | Mephedrone 200 mg, single dose, oral administration Receives: Drug: Mephedrone |
| 3,4-methylenedioxymethamphetamine | Active comparator | 3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration Receives: Drug: 3,4-methylenedioxymethamphetamine |
| Lactose | 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.
Changes in blood pressure
Systolic and diastolic blood pressure
Measured: From pre-dose (baseline) to 4h post-dose
Secondary outcomes (7)
Changes in euphoria-good effects
Euphoria-good effects effects will be measured using rating scales (visual analogue scales, the Addiction Research Center Inventory and the Evaluation of the Subjective Effects of Substances with Abuse Potential questionnaires). All these instruments include measures of euphoria-good effects and other feelings induced by psychostimulants
Measured: From pre-dose (baseline) to 4h post-dose
Area Under the Concentration-Time Curve (AUC 0-24h)
Calculation of AUC of the concentrations of mephedrone and MDMA and its metabolites in blood, urine, oral fluid and sweat.
Measured: From baseline (pre-dose, 0h) to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24h post-dose
Number of Participants with Serious and Non-Serious Adverse Events
Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators
Measured: 7 days after each substance administration
Elimination half-life
Calculation of elimination hal-life from concentrations of mephedrone, MDMA and its metabolites in plasma-blood, urine, oral fluid and sweat.
Measured: From baseline to 24h post-dose
Changes in heart rate
Measure of heart rate (pulse)
Measured: From pre-dose (baseline) to 4h post-dose
Changes in pupil diameter
Measure of pupil diameter and capacity of convergence (esophoria) using a pupillometer
Measured: From pre-dose (baseline) to 4h post-dose
Changes in oral temperature
Measure of temperature in mouth using automatic thermometer
Measured: From pre-dose (baseline) to 4h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Amphetamine-Related DisordersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Magi Farre, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232789
- Sponsor's protocol ID
- IMIMFTCL/MEF/1
- Status last verified
- Dec 2014
- First submitted
- 29 Aug 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Papaseit E, Perez-Mana C, Mateus JA, Pujadas M, Fonseca F, Torrens M, Olesti E, de la Torre R, Farre M. Human Pharmacology of Mephedrone in Comparison with MDMA. Neuropsychopharmacology. 2016 Oct;41(11):2704-13. doi: 10.1038/npp.2016.75. Epub 2016 May 20.
PubMed 27206266
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abuse Liability and Human Pharmacology of Mephedrone (4-methylmethcathinone,4-MMC)
- ClinicalTrials.gov ID
- NCT02232789
- Acronym / sponsor ID
- IMIMFTCL/MEF/1
- Conditions
- Amphetamine-Related Disorders
- Keywords
- Mephedrone, 3,4-methylenedioxymethamphetamine, Abuse liability, Human Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Sep 2014 (estimated)
- 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 this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
Detailed description
Mephedrone is a new psychoactive substance (NPS). At present, there are no randomized controlled trials evaluating the effects of mephedrone in humans. The current body of knowledge regarding the acute effects of mephedrone is based on anecdotal, self-reported effects (e.g. internet forums), case reports, and emergency room series and fatalities.
The aims of this study are 1) to evaluate the abuse liability and human pharmacology of mephedrone after oral administration and 2) to compare the pharmacological effects of mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine (MDMA, ecstasy).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mephedrone | Experimental | Drug: MephedroneMephedrone 200 mg, single dose, oral administration |
| 3,4-methylenedioxymethamphetamine | Active comparator | Drug: 3,4-methylenedioxymethamphetamine3,4-methylenedioxymethamphetamine (MDMA) 100 mg, single dose, oral administration |
| Lactose | Placebo comparator | Drug: PlaceboPlacebo, single dose, oral administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 derivatives, mephedrone or other cathinone on at least 6 occasions (two in the previous year) without serious adverse reactions.
Key exclusion criteria (11 listed)
- 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). Subjects with past history of drug abuse could be included.
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 |
|---|---|---|
| MephedroneAlso: 4-methylmethcathinone, 4-MMCSingle oral dose mephedrone | Drug | Mephedrone |
| 3,4-methylenedioxymethamphetamineAlso: MDMA, EcstasySingle oral dose MDMA | Drug | 3,4-methylenedioxymethamphetamine |
| PlaceboAlso: Non active treatmentSingle oal dose placebo | Drug | Lactose |
Primary outcome
Changes in blood pressure
Time frame: From pre-dose (baseline) to 4h post-dose
Systolic and diastolic blood pressure
7 secondary outcomes
Changes in euphoria-good effects
Time frame: From pre-dose (baseline) to 4h post-dose
Area Under the Concentration-Time Curve (AUC 0-24h)
Time frame: From baseline (pre-dose, 0h) to 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24h post-dose
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: 7 days after each substance administration
Elimination half-life
Time frame: From baseline to 24h post-dose
Changes in heart rate
Time frame: From pre-dose (baseline) to 4h post-dose
Changes in pupil diameter
Time frame: From pre-dose (baseline) to 4h post-dose
Changes in oral temperature
Time frame: From pre-dose (baseline) to 4h post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 27206266Papaseit E, Perez-Mana C, Mateus JA, Pujadas M, Fonseca F, Torrens M, Olesti E, de la Torre R, Farre M. Human Pharmacology of Mephedrone in Comparison with MDMA. Neuropsychopharmacology. 2016 Oct;41(11):2704-13. doi: 10.1038/npp.2016.75. Epub 2016 May 20.
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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 Farre, MD, PhD principal investigator
Parc de Salut Mar
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 Mephedrone and 3,4-methylenedioxymethamphetamine in people with Amphetamine-Related Disorders, run by Parc de Salut Mar 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 4 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in blood pressure (time frame: From pre-dose (baseline) to 4h post-dose). 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 NCT02232789, 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 4 Dec 2014.