Clinical TrialHealthy VolunteersMDMACompleted

Can memantine prevent memory impairment induced by MDMA in humans

This double-blind, placebo-controlled crossover trial (n=21) investigated whether memantine can mitigate memory impairment induced by MDMA in humans.

Target Enrollment
21 participants
Study Type
interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double‑blind, placebo‑controlled, four‑way crossover in recreational MDMA users (n=21). Subjects were pretreated with memantine or placebo and, two hours later, received MDMA or placebo, with a washout of at least two weeks between sessions.

Primary outcome was performance on memory tasks; secondary outcomes included event‑related potentials and speech recordings. Screening included ECG, urine and blood tests; each test day lasted approximately six hours.

Study Protocol

Preparation

sessions

Dosing

4 sessions
360 min each

Integration

sessions

Study Arms & Interventions

Crossover conditions

experimental

Four-way crossover: memantine/placebo × MDMA/placebo

Interventions

  • MDMA
    via Oral• single dose

    Dose not reported.

  • Compound
    via Oral• single dose

    Memantine (Ebixa); dose not reported.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Recreational MDMA users (≥3 lifetime uses, at least once in the past year; ≤200 lifetime uses)
  • Age 18–40 years
  • No psychotropic medication
  • Good physical health per medical examination and laboratory tests
  • No major medical, endocrine or neurological condition
  • BMI 18.5–28 kg/m2
  • Written informed consent

Exclusion Criteria

  • History of drug abuse (other than MDMA) or addiction
  • Pregnancy or lactation
  • Excessive alcohol consumption (>20 drinks/week)
  • Hypertension (diastolic >90 mmHg; systolic >140 mmHg)
  • Current or history of psychiatric disorder
  • Liver dysfunction
  • Serious adverse reactions to prior MDMA use
  • History of cardiac dysfunction (arrhythmia, ischemic heart disease)
  • For women: not using a reliable contraceptive

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment21 participants
  • Timeline
    Start: 2011-05-20
    End: 2024-01-31
  • Compound
    MDMA
  • Topic
    Healthy Volunteers

Locations

Netherlands

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