Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose

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

MDMA is a psychoactive substance that primarily enhances serotonergic neurotransmission by releasing 5-HT through the SERT. It also releases dopamine and norepinephrine, although less potently, through the dopamine transporter and norepinephrine transporter, respectively. In addition to its use as a recreational drug, MDMA-assisted psychotherapy has been investigated in several phase 2 trials and one phase 3 trial for PTSD. Further indications for MDMA-assisted therapy being planned or ongoing are eating disorders, social anxiety, and alcohol use disorder. The present study focuses on dosing aspects of MDMA used in clinical studies and recreational settings, specifically the benefits of a second administration (booster dose) given several hours after the initial dose. Most published studies of MDMA-assisted psychotherapy used a booster dose. A typical dosing regimen would be 80-120 mg of MDMA initially followed by half the initial dose after 1.5-2.5 hours. Although previous studies have found that a booster dose could prolong the acute effects of MDMA, others have shown an acute tolerance reflected in the finding that acute subjective effects return to baseline within 4-5 hours, while plasma concentrations are still close to peak levels. These findings have led to controversy regarding how effective a booster dose would be in prolonging acute effects, as it has never been directly compared to placebo. Additionally, the higher total dose could lead to an increase in side effects. Therefore, the present phase 1 study intends to compare the acute subjective, physiological, and endocrine effects of MDMA (120 mg + 60 mg after 2 hours), MDMA (120 mg + placebo after 2 hours), and (placebo + placebo after 2 hours) using a double-blind, random-order, crossover design in healthy subjects.

NCT Number NCT05809271

Data attribution

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