Comparison of R-MDMA and S-MDMA in healthy subjects

Zusammenfassung der Studie

The study examines the similarities of altered states of consciousness and emotions triggered by the enantiomers R-MDMA and S-MDMA. Enantiomers are chemical compounds that contain the same number and type of atoms. They are arranged like an image and its mirror and largely have the same physical properties. However, pharmacologically they may differ. When a substance consists of a mixture of two enantiomers in a 1:1 ratio, it is called a racemate. The effects of MDMA, a racemate, are triggered by S-MDMA and R-MDMA together. The enantiomers of MDMA are not approved as a medication, but have already been used in a study with healthy subjects. This study found that R-MDMA and S-MDMA likely induce similar effects that are comparable to MDMA. A potential therapeutic effect of S- or R-MDMA is not investigated in this study. Each morning of the study days, an intravenous catheter will be placed in the elbow. You will be connected to this venous catheter throughout the day. Measurements during the substance effect (consisting of blood draws, blood pressure, pulse, and a questionnaire) will take place in the first half of the day every 30 minutes and in the second half every 60 minutes. You will spend the entire day in a quiet room equipped with a bed at the outpatient study center of the University Hospital Basel. The experience can be intensified by slightly darkening the room and listening to music. You will be supervised throughout the entire study day.

(BASEC)

Untersuchte Intervention

The study lasts at least 6 weeks and includes a 2-hour screening visit, three study days of 9 hours each, and a 1-hour follow-up visit. The study days must be at least ten days apart, but the intervals can also be longer. Appointments will be arranged individually with you. On the four study days, you will receive:

- once R-MDMA (300 mg)

- once S-MDMA (100 mg) and

- once placebo.

The order of the study days is randomly assigned. Neither you nor your investigator knows when you will receive which substance or placebo (the study is therefore "double-blind"). This is standard in clinical trials so that knowledge of which substance is being administered does not influence the results. All subjects receive all substances, only in a different order. A study day may only be conducted if you feel well and you give your consent again before the start. In case of strong emotional distress, you should postpone the study day after consultation. Each morning of the study days, an intravenous catheter will be placed in the elbow. You will be connected to this venous catheter throughout the day. We will regularly take blood samples through this to examine the concentration of substances in the blood. As part of the entire study (screening, three study days, and follow-up visit), approximately 325 ml of blood will be drawn for analyses. This corresponds to about 75% of the amount of blood taken during a regular blood donation, spread over approximately 6 weeks. During the study days, we will determine the psychoactive effect of the substances using various questionnaires. One of them consists of a few simply formulated questions, so that it can be filled out during the effect. Questionnaires that capture complex aspects of the experience will only be filled out after the effect has subsided. During the study day, we will also repeatedly measure blood pressure, pulse, and temperature. The measurements of the substance effect will take place in the first half of the day every 30 minutes and in the second half every 60 minutes. You will spend the entire day in a quiet room equipped with a bed at the outpatient study center of the University Hospital Basel. The experience can be intensified by slightly darkening the room and listening to music. Between measurements, you will have time to read or listen to music. You will be supervised throughout the entire study day. After 8 hours, i.e., around 5 PM, the study day ends and you can go home.

In the days following the study day, you will also be asked for an appointment for a telephone interview. During the conversation, we will refer to a questionnaire that you fill out at the end of each study day. We conduct these interviews to generate a more accurate idea of the effects of the study substances. The interview may last up to an hour, but you decide how thoroughly you answer the questions. To qualitatively evaluate this interview, it will be recorded on tape.

(BASEC)

Untersuchte Krankheit(en)

Healthy subjects

(BASEC)

Sponsor

Prof. Dr. med. Matthias Liechti

(BASEC)