Clinical TrialHealthy VolunteersMDMAPlaceboPlaceboCompleted

Emotional Effects of Methylphenidate and MDMA in Healthy Subjects

Randomised, double-blind, placebo-controlled crossover in 16 healthy volunteers comparing single oral MDMA 125 mg with and without methylphenidate 60 mg (administered 1 h pre-dose).

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

Detailed Description

Randomised, double‑blind, placebo‑controlled crossover study in 16 healthy volunteers testing the role of dopamine and norepinephrine transporter blockade (methylphenidate 60 mg) on the subjective and cardiovascular effects of a single oral MDMA dose (125 mg).

Subjective and cardiovascular measures were repeatedly assessed throughout four experimental sessions; plasma samples were collected for pharmacokinetics. The primary aim was to determine whether methylphenidate attenuates MDMA’s subjective effects.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

MDMA ± MPH

experimental

Randomised, double-blind, placebo-controlled crossover with four within-subject conditions (MDMA, MDMA+MPH, MPH, placebo).

Interventions

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

    Single oral dose (125 mg).

  • Placebo60 mg
    via Oral• single dose• 1 doses total

    Methylphenidate 60 mg PO given 1 hour before MDMA/placebo.

  • Placebo
    via Oral• single dose

    Capsules identical to MDMA or methylphenidate (placebo).

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Sufficient understanding of the German language
  • Understand procedures and risks and able to give informed consent
  • Willing to adhere to protocol and refrain from illicit psychoactive substances during the study
  • Drink only alcohol-free liquids and avoid xanthine-containing liquids after midnight before study sessions
  • Not smoke tobacco 1 hour before and 4 hours after MDMA administration
  • Not drive a vehicle on the evening of the study day
  • Women of childbearing potential: negative pregnancy test at baseline and agree to effective contraception; pregnancy tests repeated before each session
  • Body mass index 18–25 kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic or acute medical condition or clinically relevant abnormality on exam, labs, or ECG (in particular 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 >5 times lifetime or any use within the previous 2 months (except THC)
  • Pregnant or nursing women
  • Participation in another clinical trial currently or within the last 30 days
  • Use of medications contraindicated or interfering with study meds (MAOIs, antidepressants, sedatives, etc.)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2011-01-12
    End: 2013-01-01
  • Compounds
    MDMAPlaceboPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Canton of Basel-City, Switzerland

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