Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)

Randomised, double-blind, crossover Phase I study (n=16) testing duloxetine (120 mg, two pre-doses) versus placebo as a pretreatment to MDMA (125 mg) in healthy volunteers to assess pharmacodynamic, cardiovascular, and pharmacokinetic effects.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Healthy volunteers undergo four experimental sessions in a randomised double-blind crossover comparing duloxetine 120 mg (two pre-doses) or placebo with MDMA 125 mg or placebo; subjective, cardiovascular and plasma PK measures are collected repeatedly.

Primary aim is to determine whether combined 5-HT and NE reuptake inhibition by duloxetine attenuates MDMA-induced subjective and cardiovascular effects and alters MDMA pharmacokinetics.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Duloxetine + MDMA

experimental

Randomised, double-blind, within-subject crossover with four sessions testing duloxetine or placebo pretreatment and MDMA or placebo.

Interventions

  • MDMA125 mg
    via Oral• single dose
  • Placebo120 mg
    via Oral• two doses• 2 doses total

    Duloxetine 120 mg given as two pre-doses before MDMA; timing reported inconsistently in source text (16 h & 4 h vs 12 h & 2 h).

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Sufficient understanding of the German language
  • Subjects understand the procedures and the risks associated with the study
  • Participants must be willing to adhere to the protocol and sign the consent form
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
  • Body mass index: 18-25 kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
  • Current or previous psychotic or affective disorder
  • Psychotic or affective disorder in first-degree relatives
  • Prior illicit drug use (except THC (Tetrahydrocannabinol)-containing products) more than 5 times or any time within the previous 2 months.
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2009-01-11
    End: 2010-01-05
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Basel, Switzerland

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