This Phase I study investigates the acute effects of MDMA (120 + 60mg) with and without a booster dose, involving healthy subjects. The trial is a double-blind, random-order, crossover design with three interventions: MDMA with booster, MDMA without booster (120 mg + placebo), and placebo + placebo.
The study aims to compare subjective, physiological, and endocrine effects. The primary outcome is the duration of “any drug effect,” assessed through visual analogue scales. The trial, led by Prof. Dr. Matthias E Liechti, started on November 17, 2023, with an estimated completion date of December 31, 2025, and an estimated enrollment of 24 participants. The study takes place at the University Hospital in Basel, Switzerland, with contact details provided for Prof. Dr. Matthias E Liechti and Dr. Lorenz Müller. Eligibility criteria include a good understanding of German, adherence to the protocol, refraining from psychoactive substances, and BMI between 18-29 kg/m². Exclusion criteria involve relevant medical conditions, psychiatric disorders, hypertension, and previous extensive MDMA use.
The study design is a 3-period, random-order, placebo-controlled, double-blind crossover, and the primary purpose is basic science. The study will assess various subjective and physiological measures, including blood pressure, heart rate, body temperature, adverse effects, and subacute effects on general and mental well-being. Additionally, the study will explore the moderation effects of personality traits on MDMA responses. Publications related to the study are not available as of the latest update in November 2023.
Trial Details
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Sponsors & Collaborators
University of BaselThe University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.