Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

The role of 5-HT2 and 5-HT1A receptors in 3,4-methylenedioxymethamphetamine (MDMA) induced memory impairment and impulsivity.

Double-blind, randomised, six-condition crossover study (n=18) testing MDMA 75 mg with ketanserin 50 mg, pindolol 20 mg, and placebo to probe 5-HT2 and 5-HT1A contributions to MDMA-induced memory impairment and impulsivity in experienced MDMA users.

Target Enrollment
18 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind
Registry
NTR / NL2227

Detailed Description

Randomised, double-blind, double-dummy crossover in experienced MDMA users comparing six treatment conditions: MDMA 75 mg alone, MDMA+ketanserin 50 mg, MDMA+pindolol 20 mg, ketanserin alone, pindolol alone, and placebo.

Primary outcomes are neurocognitive measures of memory and impulse control assessed at Tmax; interventions synchronise Tmax using double-dummy administration.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

MDMA combinations

experimental

Six-condition double-blind crossover comparing MDMA 75 mg with ketanserin 50 mg, pindolol 20 mg, and placebo in various combinations (double-dummy).

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total

    MDMA 75 mg as 25 ml solution in bitter orange peel syrup

  • Compound50 mg
    via Oral• single dose

    Ketanserin 50 mg capsule (5-HT2 antagonist); double-dummy

  • Compound20 mg
    via Oral• single dose

    Pindolol 20 mg capsule (5-HT1A/adrenergic agent); double-dummy

  • Placebo
    via Oral• single dose

    Matching placebo (double-dummy)

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • 1. Between 18 and 40 years of age;
  • 2. Experience with the use of MDMA (at least 5 times, of which no less than one in the past 12 months);
  • 3. Free from psychotropic medication;
  • 4. Good physical health as determined by examination and laboratory analysis;
  • 5. Absence of any major medical, endocrine and neurological condition;
  • 6. Normal weight, body mass index (weight/length2) between 18 and 28 kg/m2;
  • 7. Health insurance;
  • 8. Written informed consent.

Exclusion Criteria

  • 1. History of drug abuse (other than the use of MDMA) or addiction;
  • 2. Pregnancy or lactation;
  • 3. Cardiovascular abnormalities as assessed by standard 12-lead ECG;
  • 4. Excessive drinking (> 20 standard alcoholic consumptions a week);
  • 5. Smoking (>10 cigarettes a day);
  • 6. Hypertension (diastolic > 100; systolic > 170);
  • 7. Use of psychotropic medication;
  • 8. History of psychiatric or neurological disorder.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment18 participants
  • Timeline
    Start: 2010-03-01
    End: 2011-01-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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