NCT01447472

Brief Summary

The purpose of this study are:

  1. 1.to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
  2. 2.to evaluate gender differences in the human pharmacology of MDMA
  3. 3.to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

6 years

First QC Date

September 27, 2011

Last Update Submit

October 5, 2011

Conditions

MetabolismInteraction

Keywords

MDMA,pharmacokinetics,pharmacodynamics,CYP2D6, COMT,SERT, 5-HTTLPR, gender,dextromethorphan,caffeine.

Outcome Measures

Primary Outcomes (4)

  • Concentrations of dextromethorphan in plasma and urine.

    Blood samples and urine to determine dextromethorphan and dextrorphan concentrations until 240h.

    240 hours after MDMA dosing.

  • Concentrations of caffeine in plasma and urine.

    Blood samples and urine to determine caffeine and theobromine concentrations until 240h.

    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.

    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.

    48h after MDMA administration.

Secondary Outcomes (2)

  • Effects of MDMA on physiological response.

    24h

  • Effects of MDMA on physiological response.

    24h

Study Arms (1)

MDMA

EXPERIMENTAL

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

Drug: MDMA

Interventions

MDMADRUG

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

Also known as: Ecstasy
MDMA

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (3)

  • 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.

    PMID: 21456632RESULT

  • 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.

    PMID: 18794647RESULT

  • 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.

    PMID: 23112822DERIVED

MeSH Terms

Conditions

Coitus

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Magí Farre, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 6, 2011

Study Start

May 1, 2003

Primary Completion

May 1, 2009

Study Completion

May 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

ES(1)