Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK)

Randomised, double‑blind, crossover pharmacology study in healthy volunteers (n=16) testing reboxetine (8 mg, two doses) on subjective and cardiovascular effects of MDMA (125 mg).

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

Detailed Description

This randomised, double‑blind, crossover study in 16 healthy volunteers tests whether the selective norepinephrine transporter inhibitor reboxetine attenuates the subjective and cardiovascular stimulant effects of a single oral MDMA dose (125 mg).

Reboxetine (8 mg) or placebo is given the night before and ~1 hour before each session; MDMA or placebo is administered in four counterbalanced sessions. Outcomes include repeated measures of subjective effects, heart rate, blood pressure and plasma PK. The study aims to clarify norepinephrine’s contribution to MDMA’s pharmacology.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

MDMA ± Reboxetine

experimental

Randomised, double-blind, crossover with four experimental sessions testing MDMA and reboxetine/placebo combinations in the same subjects.

Interventions

  • MDMA125 mg
    via Oral• single dose• 1 doses total

    Single oral MDMA 125 mg

  • Compound8 mg
    via Oral• two doses• 2 doses total

    Reboxetine 8 mg administered night before and ~1 h before session (two doses)

  • Placebo
    via Oral• single dose

    Placebo capsules identical to MDMA or reboxetine

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Sufficient understanding of German; understand procedures and risks; willing to adhere to protocol and sign consent; refrain from illicit psychoactive substances during study; alcohol-free and no xanthine-containing liquids after midnight before session; agree not to smoke tobacco 1 h before and 4 h after MDMA; not to drive in evening of study day; women of childbearing potential must have negative pregnancy test before each session and use effective contraception; BMI 18-25 kg/m2.

Exclusion Criteria

  • Chronic or acute medical condition or clinically relevant abnormality in physical exam, labs, or ECG (notably hypertension >140/90 mmHg); personal or first-degree 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) >5 times lifetime or any use within previous 2 months; pregnant or nursing; participation in another clinical trial currently or within last 30 days; use of medications contraindicated or interfering with study drugs (MAOIs, antidepressants, sedatives, etc.).

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2009-01-04
    End: 2010-01-03
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital — Basel, Switzerland

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