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-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms

NCT ID: NCT01447472

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2011-05-31

Brief Summary

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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. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.

Detailed Description

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Conditions

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Metabolism Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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MDMA

One single dose of MDMA (1.5 mg/kg; range 75-100 mg)

Group Type EXPERIMENTAL

MDMA

Intervention Type DRUG

One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)

Interventions

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MDMA

One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)

Intervention Type DRUG

Other Intervention Names

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Ecstasy

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magí Farre, PhD

Role: PRINCIPAL_INVESTIGATOR

IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)

Locations

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IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar)

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 21456632 (View on PubMed)

O'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.

Reference Type RESULT
PMID: 18794647 (View on PubMed)

Pardo-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.

Reference Type DERIVED
PMID: 23112822 (View on PubMed)

Other Identifiers

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AEMPS no.04-0013

Identifier Type: OTHER

Identifier Source: secondary_id

5R01DA017987

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMIMFTCL/MDMA/6

Identifier Type: -

Identifier Source: org_study_id