Clinical TrialPublic Health, Prevention & Behaviour ChangeMDMAPlaceboPlaceboCompleted

Effects of alcohol (0.5 g/kg) and MDMA (100 mg) on (simulated) driving performance, driving related performance and traffic safety

Double-blind, placebo-controlled, 4-way crossover study (n=20) testing single-dose oral MDMA (100 mg), alcohol (0.5 g/kg), and their combination on simulated driving and driving-related cognitive performance in experienced MDMA users.

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

Detailed Description

A four-period, double-blind, placebo-controlled crossover (Latin-square counterbalanced) in 20 experienced MDMA users assessing effects of single oral doses of MDMA (100 mg), alcohol (0.5 g/kg), their combination, and placebo on simulated driving performance.

Primary outcomes are driving- and driving-related task performance assessed on strategic, manoeuvring and control levels; secondary measures include biological samples for drug levels and questionnaires. Driving tests occurred 1.5 hours after MDMA and 20 minutes after alcohol intake; cognitive tasks followed approximately 2.5 hours post-MDMA.

Safety monitoring included vitals, ECG, adverse event reporting and procedures for prompt reporting of serious adverse events to the ethics committee and treating clinicians.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

MDMA/alcohol crossover

experimental

Four-period, double-blind, placebo-controlled crossover with counterbalanced Latin-square ordering: MDMA, alcohol, MDMA+alcohol, and placebo conditions.

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total

    Single oral dose MDMA 100 mg.

  • Placebo0.5 g/kg
    via Oral• single dose

    Alcohol 0.5 g/kg (active condition); compound ref set to placebo placeholder and dose recorded in notes.

  • Placebo
    via Oral• single dose

    Placebo matching MDMA and alcohol.

Participants

Ages
21 – 40
Sexes
Male & Female

Inclusion Criteria

  • Experience with the use of MDMA (at least 5 times in the past 12 months)
  • Experience with the use of alcohol (<2 or >20 alcoholic consumptions a week)
  • Free from psychotropic medication
  • Good physical health as determined by examination and laboratory analysis
  • Absence of any major medical, endocrine and neurological condition
  • Normal weight, body mass index (weight/length^2) between 18 and 28 kg/m2
  • Valid driving license
  • Written informed consent

Exclusion Criteria

  • History of drug abuse or addiction as determined by examination
  • Pregnancy, lactation or wishing to become pregnant in the period of the study
  • Cardiovascular abnormalities as assessed by standard ECG
  • Excessive drinking (>20 alcoholic consumptions a week)
  • Hypertension (diastolic >100; systolic >170)
  • Current or history of psychiatric disorder
  • Participation in any clinical trial including blood sampling and/or administration of substances up to 6 weeks before Day 01 of this study
  • History of malignant hyperthermia/serotonin syndrome
  • Susceptibility to simulator sickness (subjects will be pre-tested)
  • Heavy smoking: during the visit smoking is restricted to breaks
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner

Study Details

Locations

Netherlands

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