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.
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.
Four-period, double-blind, placebo-controlled crossover with counterbalanced Latin-square ordering: MDMA, alcohol, MDMA+alcohol, and placebo conditions.
Single oral dose MDMA 100 mg.
Alcohol 0.5 g/kg (active condition); compound ref set to placebo placeholder and dose recorded in notes.
Placebo matching MDMA and alcohol.