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Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.
MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine (DA), norepinephrine (NE), serotonin (5-HT), and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin (PRL). Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. A human study conducted between 10/2022 and 01/2024 by our team compared the effects of R-MDMA, S-MDMA, and racemic MDMA revealing that both enantiomers have generally similar effects. However, the study did not administer equivalent doses of R- and S-MDMA. In the present study a single dose of R-MDMA and a single dose of S-MDMA, now adjusted and presumed to be equivalent, will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300mg R-MDMA | Experimental | R-MDMA (300mg) |
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| 100mg S-MDMA | Experimental | S-MDMA (100mg) |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-3,4-methylenedioxymethamphetamine | Drug | A dose of 300mg enantiomeric R-MDMA will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective effects | Any drug effect on the Visual Analog Scales (VAS) assessing the intensity and duration of the subjective effect on a scale from 0 - 100 percent with higher scores representing more intense effects 14 times each study day. | through study completion, an average of 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic effects I | Blood pressure (systolic and diastolic) will be measured with an automatic oscillometric device 14 times each study day. | Through study completion, an average of 18 months. |
| Autonomic effects II |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias E Liechti, Prof. Dr. MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
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double-blind, placebo-controlled, 3-period cross-over design with two treatment conditions and placebo: 1. R-MDMA (300mg), 2. S-MDMA (100mg), 3. Placebo
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| S-3,4-methylenedioxymethamphetamine | Drug | A dose of 100mg enantiomeric S-MDMA will be administered. |
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| Placebo | Other | Placebo (Mannitol) |
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Heart rate will be measured with an automatic oscillometric device. Assessed 14 times on each study day.
| Through study completion, an average of 18 months. |
| Autonomic effects III | Body temperature will be measured with an ear thermometer. Assessed 14 times each study day. | through study completion, an average of 18 months. |
| Plasma levels of oxytocin | Assessed 3 times on each study day | Through study completion, an average of 18 months. |
| Plasma levels of cortisol | Assessed 3 times on each study day | Through study completion, an average of 18 months. |
| Plasma levels of prolactin | Assessed 3 times on each study day | Through study completion, an average of 18 months. |
| Plasma levels of R-MDMA | Assessed 13 times on each study day | Through study completion, an average of 18 months. |
| Plasma levels of S-MDMA | Assessed 13 times on each study day | Through study completion, an average of 18 months. |
| Additional subjective effects I | Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 14 times on each study day | Through study completion, an average of 18 months. |
| Additional subjective effects II | Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely" assessed 4 times on each study day | Through study completion, an average of 18 months. |
| Additional subjective effects III | This world connectogen scale (TWCS) assessing the connectogenic properties of MDMA as a strong sense of connection with the here-and-now, the body, the world and spiritual principles. Assessed once each study day | Through study completion, an average of 18 months. |
| NEO-Five-Factor-Inventory (NEO-FFI) | The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree". | Baseline |
| Freiburger Personality Inventory (FPI-R) | The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true"). | Baseline |
| Saarbrücken Personality Questionnaire (SPF) | Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Saarbrücker Persönlichkeitsfragebogen (SPF) defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items. | Baseline |
| HEXACO personality inventory | Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience. | Baseline |
| Defense Style Questionnaire (DSQ-40) | Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Defense Style Questionnaire (DSQ-40) can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree". | Baseline |
| Acute adverse effects | Assessed twice on each study day with the list of complaints (LC) | Through study completion, an average of 18 months. |
| Subacute adverse effects I | The List of complains is a list of 50 symptoms assessed on a 4-point Likert scale ranging from "not at all" to "extremely". Assessed twice (24 and 72h) after each study day. | Through study completion, an average of 18 months. |
| Subacute adverse effects II | The Beck Depressionindex questionnaire (BDI) is assessed once after each study day (72h) with low values indicating normal mood and high values indicating severe depression. | Through study completion, an average of 18 months. |
| Dose equivalence I | 5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects. Assessed once on each study day | Through study completion, an average of 18 months. |
| Dose equivalence II | The State of Consciousness (SCQ) Questionaire assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day | Through study completion, an average of 18 months. |
| Life satisfaction and well-being I | The Scale of positive and negative experience (SPANE) assesses 12 items of subject well-being on a 5-point-scale ranging from "very rarely" to "very often or always". Assessed once each study day and 72 h after administration. | Through study completion, an average of 18 months. |
| Life satisfaction and well-being II | The "positive attitude towards life" is an 8-item subscale of the Berner Subjective Well-Being Quetsionaire for adults (BFW/E) using a six-point rating scale from "strongly disagree" (1) to "strongly agree" (6) to rate the attitude towards life. Assessed once each study day. | Through study completion, an average of 18 months. |
| Life satisfaction and well-being III | The Global Life Satisfaction (GLS) assesses the overall satisfaction on a 11 point scale with 0 meaning "not at all satisfied" and 10 meaning "completely satisfied". Assessed once each study day as well as 72 h after each drug adminstration. | Through study completion, an average of 18 months. |
| Life satisfaction and well-being IV | The Appreciation Scale (AS) includes 57 items to measure eight aspects of appreciation. Subjects are asked to rate themselves on a scale from 1 to 7 in terms of either attitude intensity ('strongly disagree' to 'strongly agree') or frequency ('never' to 'more than once a day'). Assessed at screening and end of study visit. | Baseline/End of Study Visit |
| Empathogenic effects I | Multifaceted Empathy Test (MET), effects on empathy in computer tests, assessed one time during each study session. | Through study completion, an average of 18 months. |
| Empathogenic effects II | Facial expression recognition test (FERT), effects on empathy in computer tests, assessed one time during each study session. | Through study completion, an average of 18 months. |