Clinical TrialHealthy VolunteersMDMACompleted

Can memantine prevent memory impairment induced by MDMA in humans.

This double-blind, placebo-controlled crossover trial (n=16) investigates whether pretreatment with memantine can prevent the memory impairment typically caused by MDMA in recreational users.

Target Enrollment
16 participants
Study Type
Phase NA interventional
Design
Non-randomized, double Blind
Registry
NTR / NL2664

Detailed Description

Randomised design not specified in registry; double-blind, placebo-controlled four-way crossover in recreational MDMA users. Subjects receive memantine 20 mg or placebo, and 2 hours later receive MDMA 75 mg or placebo, with at least a one-week washout between sessions (4 sessions total).

Primary outcome is memory performance measured immediately after each treatment using verbal and prospective memory tests. Secondary measures include event-related potentials (P300) and perceptual/speech analyses.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Memantine + MDMA

experimental

Four-way, double-blind crossover with memantine/placebo pretreatment and MDMA/placebo challenge.

Interventions

  • Compound20 mg
    via Oral• single dose

    Memantine 20 mg PO given ~2 hours before challenge.

  • MDMA75 mg
    via Oral• single dose

    Single oral MDMA 75 mg.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • 1. Recreational MDMA users;
  • 2. Age between 18 and 40 years;
  • 3. Free from psychotropic medication;
  • 4. Good physical health;
  • 5. Absence of any major medical, endocrine and neurological condition;
  • 6. Normal weight;
  • 7. Written informed consent.

Exclusion Criteria

  • 1. History of drug abuse (other than the use of MDMA) or addiction;
  • 2. Pregnancy or lactation;
  • 3. Excessive drinking;
  • 4. Hypertension;
  • 5. Current or history of psychiatric disorder.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomizeddouble Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2011-04-01
    End: 2012-01-01
  • Compound
    MDMA
  • Topic
    Healthy Volunteers

Locations

Netherlands

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