Effects of MDMA-like Substances in Healthy Subjects

Summary

The serotonin (5-HT) and oxytocin releaser and so-called "empathogen" 3,4-methylenedioxymethamphetamine (MDMA) acutely produces positive feelings, empathy, and trust. MDMA is used recreationally (ecstasy), as research tool to study 5-HT and oxytocin function, and is investigated for MDMA-assisted psychotherapy.

MDMA is metabolized in part (10%) to the psychoactive metabolite 3,4-methylenedioxyamphetamine (MDA) which itself is also a recreational substance and has also been used to assist psychotherapy in the past. The present study aims to describe and directly compare for the first time the effects of MDMA and MDA in the same healthy volunteers and using modern psychological and psychometric tests.

Additionally, although amphetamines including MDMA and MDA induce mainly positive subjective effects they may also produce negative subjective drug effects including anxiety in particular at the onset of the subjective response and the rapid onset of euphoria may increase the risk of abuse. Additionally, blood pressure may increase rapidly at drug onset. A possible solution to mitigate anxiety, abuse-related rapid euphoria increases and/or rapid blood pressure changes at onset consist of slowing the onset of the drug effect by using a slow-release formulation of MDMA. In the present study, the investigators will characterize the effects of lysine-MDMA and lysine-MDA and compare their effects with MDMA/MDA to test the concept of attenuated effects across both substances.

Conditions

• Healthy

Interventions

DRUG

3,4-methylenedioxymethamphetamine

A moderate dose of 100 mg MDMA will be administered.

DRUG

3,4-methylenedioxyamphetamine

A moderate dose of 93.9 mg MDA will be administered.

DRUG

lysine-3,4-methylenedioxymethamphetamine

A moderate dose of 171.7 mg lysine-MDMA will be administered.

DRUG

lysine-3,4-methylenedioxyamphetamine

A moderate dose of 165.6 mg lysine-MDA will be administered.

OTHER

Placebo

Placebo (Mannitol)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Matthias E Liechti, Prof. Dr. MD · University Hospital, Basel, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2024-06-18

Completion

2024-06-18

Countries

• Switzerland

Study Locations