Comparison of R-MDMA and S-MDMA in healthy subjects
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
Healthy subjects
(BASEC)
- Age between 18 and 65 years - Good understanding of the German language - Body mass index between 18 – 34.9 kg/m² - Understanding of the procedures and risks associated with the study - Willingness to adhere to the protocol and sign the consent form - Willingness to refrain from consuming illegal psychoactive substances during the study - Willingness not to operate heavy machinery within 48 hours after administration of a study substance - Willingness to use an effective method of contraception throughout the study participation (BASEC)
Exclusion criteria
- Relevant chronic or acute medical condition - Current or past severe psychiatric disorder (e.g., psychotic disorder), current depression or anxiety disorder - Psychotic disorder or bipolar disorder in first-degree relatives - Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg) - Pregnancy or current breastfeeding - Participation in another clinical study (currently or in the last 30 days) - Use of medications that could affect the action of the study medication - Tobacco smoking (>10 cigarettes/day) - Excessive consumption of alcoholic beverages (>15 drinks/week) (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Prof. Dr. med. Matthias Liechti
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Matthias Liechti
+41 61 328 68 68
matthias.liechti@clutterusb.chUniversitätsspital Basel
(BASEC)
General Information
University Hospital, Basel, Switzerland
61 328 68 6861 328 68 68
matthias.liechti@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
08.10.2024
(BASEC)
ICTRP Trial ID
NCT06905652 (ICTRP)
Official title (approved by ethics committee)
Comparative acute effects of R-MDMA and S-MDMA in healthy participants (BASEC)
Academic title
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants (ICTRP)
Public title
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants (ICTRP)
Disease under investigation
Healthy (ICTRP)
Intervention under investigation
Drug: R-3,4-methylenedioxymethamphetamineDrug: S-3,4-methylenedioxymethamphetamineOther: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
1. Age between 18 and 65 years
2. Good understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during
the study
6. Willing not to operate heavy machinery within 48 h after administration of a study
substance (including driving a car)
7. Willing to use effective birth-control throughout study participation.
8. Body mass index 18 - 34.9 kg/m2
Exclusion Criteria:
1. Relevant chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. bipolar disorder,
schizophrenia), current depression or anxiety disorder
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
5. Illicit substance use (not including cannabis) more than 20 times or any time within
the previous month.
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medications that may interfere with the effects of the study medication
9. Tobacco smoking (>10 cigarettes/day).
10. Excessive consumption of alcoholic beverages (>15 drinks/week) (ICTRP)
not available
Primary and secondary end points
Subjective effects (ICTRP)
Autonomic effects I;Autonomic effects II;Autonomic effects III;Plasma levels of oxytocin;Plasma levels of cortisol;Plasma levels of prolactin;Plasma levels of R-MDMA;Plasma levels of S-MDMA;Additional subjective effects I;Additional subjective effects II;Additional subjective effects III;NEO-Five-Factor-Inventory (NEO-FFI);Freiburger Personality Inventory (FPI-R);Saarbr�cken Personality Questionnaire (SPF);HEXACO personality inventory;Defense Style Questionnaire (DSQ-40);Acute adverse effects;Subacute adverse effects I;Subacute adverse effects II;Dose equivalence I;Dose equivalence II;Life satisfaction and well-being I;Life satisfaction and well-being II;Life satisfaction and well-being III;Life satisfaction and well-being IV;Empathogenic effects I;Empathogenic effects II (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Matthias E Liechti, Prof. Dr. MDMatthias E Liechti, Prof. Dr. MDMatthias E Liechti, Prof. Dr. MD, matthias.liechti@usb.chmatthias.liechti@usb.ch, 61 328 68 6861 328 68 68, University Hospital, Basel, Switzerland (ICTRP)
Secondary trial IDs
BASEC 2024-01835 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06905652 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available