MetabolismPhase 1NCT01447472
-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms
A Phase 1 study testing MDMA in people with Metabolism and Interaction, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The purpose of this study are: 1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism 2. to evaluate gender differences in the human pharmacology of MDMA 3. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Interaction
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- May 2003to May 2011
- 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
- Healthy male and female adults, the recreational use of MDMA on at least ten occasions (two in the previous year), and the EM phenotype for CYP2D6 activity determined using dextromethorphan as a selective probe drug.
- Women had to present a regular menstrual cycle and not take oral contraceptives.
Who cannot join
- Daily consumption >20 cigarettes and >4 standard units of ethanol in men (>2 in women)
- Regular ingestion of medication in the month preceding the study
- Presence of major psychiatric disorders
- History of abuse or drug dependence (except for nicotine dependence)
- Psychiatric adverse reactions after MDMA consumption.
Trial locations and contacts
1 site in 1 country.
Spain1 site
IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
Barcelona, Barcelona, 08003
About this study
Official title: Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine
The purpose of this study are:
- to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
- to evaluate gender differences in the human pharmacology of MDMA
- to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.
- Conditions
- Metabolism, Interaction
- Being tested
- MDMA
- Keywords
- MDMA,, pharmacokinetics,, pharmacodynamics,, CYP2D6, COMT,, SERT, 5-HTTLPR, gender,, dextromethorphan,, caffeine.
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Also called Ecstasy
One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
| Study group | Role | What they receive |
|---|---|---|
| MDMA | Experimental | One single dose of MDMA (1.5 mg/kg; range 75-100 mg) Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of dextromethorphan in plasma and urine.
Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.
Measured: 240 hours after MDMA dosing.
Concentrations of caffeine in plasma and urine.
Blood samples and urine to determine caffeine and theobromine concentrations until 240h.
Measured: 24 hours after MDMA dosing.
Concentrations of MDMA and metabolites (influence of gender)
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gender male/female.
Measured: 48h after MDMA administration.
Concentrations of MDMA and metabolites (influence of genetics)
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gene polymorphisms of CYP2D6, CYP3A4, COMT, SERT.
Measured: 48h after MDMA administration.
Secondary outcomes (2)
Effects of MDMA on physiological response.
Effects of MDMA on blood preassure, heart rate, temperature, pupil diameter, esophoria. Influence of gender and genetic polymorphisms.
Measured: 24h
Effects of MDMA on physiological response.
Effects of MDMA on subjective effects (feelings of intoxication, euphoria, bad effects etc) and psychological tests (VESSPA, ARCI). Influence of gender and genetic polymorphisms.
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startMay 2003
- Primary completionMay 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Magí Farre, PhD, Principal investigator, IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447472
- Sponsor's protocol ID
- IMIMFTCL/MDMA/6
- Other IDs
- AEMPS no.04-0013, 5R01DA017987
- Status last verified
- Oct 2011
- First submitted
- 27 Sep 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yubero-Lahoz S, Pardo R, Farre M, O'Mahony B, Torrens M, Mustata C, Perez-Mana C, Carbo ML, de la Torre R. Sex differences in 3,4-methylenedioxymethamphetamine (MDMA; ecstasy)-induced cytochrome P450 2D6 inhibition in humans. Clin Pharmacokinet. 2011 May;50(5):319-29. doi: 10.2165/11584550-000000000-00000.
PubMed 21456632O'Mathuna B, Farre M, Rostami-Hodjegan A, Yang J, Cuyas E, Torrens M, Pardo R, Abanades S, Maluf S, Tucker GT, de la Torre R. The consequences of 3,4-methylenedioxymethamphetamine induced CYP2D6 inhibition in humans. J Clin Psychopharmacol. 2008 Oct;28(5):523-9. doi: 10.1097/JCP.0b013e318184ff6e.
PubMed 18794647Pardo-Lozano R, Farre M, Yubero-Lahoz S, O'Mathuna B, Torrens M, Mustata C, Perez-Mana C, Langohr K, Cuyas E, Carbo Ml, de la Torre R. Clinical pharmacology of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"): the influence of gender and genetics (CYP2D6, COMT, 5-HTT). PLoS One. 2012;7(10):e47599. doi: 10.1371/journal.pone.0047599. Epub 2012 Oct 24.
PubMed 23112822
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Study of the Metabolic Changes Induced by 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) in the Metabolism of Dextromethorphan and Caffeine
- ClinicalTrials.gov ID
- NCT01447472
- Acronym / sponsor ID
- IMIMFTCL/MDMA/6
- Conditions
- Metabolism, Interaction
- Keywords
- MDMA,, pharmacokinetics,, pharmacodynamics,, CYP2D6, COMT,, SERT, 5-HTTLPR, gender,, dextromethorphan,, caffeine.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Oct 2011 (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 purpose of this study are:
- to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
- to evaluate gender differences in the human pharmacology of MDMA
- to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA | Experimental | Drug: MDMAOne single dose of MDMA (1.5 mg/kg; range 75-100 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female adults, the recreational use of MDMA on at least ten occasions (two in the previous year), and the EM phenotype for CYP2D6 activity determined using dextromethorphan as a selective probe drug.
- Women had to present a regular menstrual cycle and not take oral contraceptives.
Key exclusion criteria (5 listed)
- Daily consumption >20 cigarettes and >4 standard units of ethanol in men (>2 in women)
- Regular ingestion of medication in the month preceding the study
- Presence of major psychiatric disorders
- History of abuse or drug dependence (except for nicotine dependence)
- Psychiatric adverse reactions after MDMA consumption.
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 |
|---|---|---|
| MDMAAlso: EcstasyOne single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg) | Drug | MDMA |
Primary outcome
Concentrations of dextromethorphan in plasma and urine.
Time frame: 240 hours after MDMA dosing.
Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.
Concentrations of caffeine in plasma and urine.
Time frame: 24 hours after MDMA dosing.
Blood samples and urine to determine caffeine and theobromine concentrations until 240h.
Concentrations of MDMA and metabolites (influence of gender)
Time frame: 48h after MDMA administration.
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gender male/female.
Concentrations of MDMA and metabolites (influence of genetics)
Time frame: 48h after MDMA administration.
Determination of MDMA and metabolites concentrations in plasma and urine during 48h. Influence of gene polymorphisms of CYP2D6, CYP3A4, COMT, SERT.
2 secondary outcomes
Effects of MDMA on physiological response.
Time frame: 24h
Effects of MDMA on physiological response.
Time frame: 24h
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 6 Oct 2011.
- Results publication: PubMed 21456632Yubero-Lahoz S, Pardo R, Farre M, O'Mahony B, Torrens M, Mustata C, Perez-Mana C, Carbo ML, de la Torre R. Sex differences in 3,4-methylenedioxymethamphetamine (MDMA; ecstasy)-induced cytochrome P450 2D6 inhibition in humans. Clin Pharmacokinet. 2011 May;50(5):319-29. doi: 10.2165/11584550-000000000-00000.
- Results publication: PubMed 18794647O'Mathuna B, Farre M, Rostami-Hodjegan A, Yang J, Cuyas E, Torrens M, Pardo R, Abanades S, Maluf S, Tucker GT, de la Torre R. The consequences of 3,4-methylenedioxymethamphetamine induced CYP2D6 inhibition in humans. J Clin Psychopharmacol. 2008 Oct;28(5):523-9. doi: 10.1097/JCP.0b013e318184ff6e.
- Derived from this study: PubMed 23112822Pardo-Lozano R, Farre M, Yubero-Lahoz S, O'Mathuna B, Torrens M, Mustata C, Perez-Mana C, Langohr K, Cuyas E, Carbo Ml, de la Torre R. Clinical pharmacology of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"): the influence of gender and genetics (CYP2D6, COMT, 5-HTT). PLoS One. 2012;7(10):e47599. doi: 10.1371/journal.pone.0047599. Epub 2012 Oct 24.
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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.
Magí Farre, PhD principal investigator
IMIM-Hospital del Mar (Institut de Recerca Hospital del 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 MDMA in people with Metabolism and Interaction, 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 2 inclusion and 5 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 6 Oct 2011. 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. 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?
Concentrations of dextromethorphan in plasma and urine. (time frame: 240 hours after MDMA dosing.). The study lists 4 primary outcomes in all. 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 NCT01447472, which also lists 3 linked publications.
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 6 Oct 2011.