A Phase 1 interventional study of 3,4-methylenedioxymethamphetamine and S-3,4-methylenedioxymethamphetamine in Healthy, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by University Hospital, Basel, Switzerland · Phase 1, Interventional, and Basic science
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 is currently 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, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. 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. However, acute effects of S- and R-MDMA have never been validly examined in a human study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and placebo in a cross-over study in healthy subjects.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
MDMA (125 mg)
Drug: 3,4-methylenedioxymethamphetamine
S-MDMA (125 mg)
Drug: S-3,4-methylenedioxymethamphetamine
R-MDMA (125 mg)
Drug: R-3,4-methylenedioxymethamphetamine (125 mg)
R-MDMA (250 mg)
Drug: R-3,4-methylenedioxymethamphetamine (250 mg)
Placebo
Other: Placebo
A dose of 125 mg racemic MDMA will be administered.
Also known as: MDMA
A dose of 125 mg enantiomeric S-MDMA will be administered.
Also known as: S-MDMA
A dose of 125 mg enantiomeric R-MDMA will be administered.
Also known as: R-MDMA
A dose of 250 mg enantiomeric R-MDMA will be administered.
Also known as: R-MDMA
Placebo (Mannitol)
Subjective effects 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
Time frame: 18 months
Subjective effects II
Stimulation on the Visual Analog Scales (VAS) assessing the intensity and duration of the stimulant effect on a scale from 0 - 100 percent with higher scores representing more intense effects. Assessed 18 times on each study day
Time frame: 18 months
Autonomic effects I
Assessed 18 times on each study day via systolic and diastolic blood pressure
Time frame: 18 months
Autonomic effects II
Assessed 18 times on each study day via heart rate
Time frame: 18 months
Autonomic effects III
Assessed 18 times on each study day via tympanic body temperature
Time frame: 18 months
Adverse effects
Assessed 3 times on each study day with the list of complaints (LC)
Time frame: 18 months
Mood after study day I
Assessed once 3 days after administration via the Beck Depressionindex questionnaire (BDI) with low values indicating normal mood and high values indicating severe depression
Time frame: 18 months
Mood after study day II
Assessed once 3 days after administration via Symptom checklist 90R (SCL-90R) to evaluate a number of different psychological symptoms.
Time frame: 18 months
Mood after study day III
Assessed once 3 days after administration via list of complaints (LC)
Time frame: 18 months
Mood after study day IV
Assessed once 3 days after administration via adjective mood rating scale (AMRS)
Time frame: 18 months
Plasma levels of cortisol
Assessed 3 times on each study day
Time frame: 18 months
Plasma levels of prolactin
Assessed 3 times on each study day
Time frame: 18 months
Plasma levels of oxytocin
Assessed 4 times on each study day
Time frame: 18 months
Plasma levels of vasopressin
Assessed 4 times on each study day
Time frame: 18 months
Plasma levels of S-MDMA
Assessed 17 times on each study day
Time frame: 18 months
Plasma levels of R-MDMA
Assessed 17 times on each study day
Time frame: 18 months
Plasma levels of S-MDA
Assessed 17 times on each study day
Time frame: 18 months
Plasma levels of R-MDA
Assessed 17 times on each study day
Time frame: 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 18 times on each study day
Time frame: 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
Time frame: 18 months
States of Consciousness Questionnaire
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
Time frame: 18 months
Spiritual Realms Questionnaire
Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales once on each study day
Time frame: 18 months
Psychological Insight Questionnaire
Assesses the degree of psychological insight caused by a psychedelic experience through 14-items to be answered on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely") once on each study day
Time frame: 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".
Time frame: 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").
Time frame: Baseline
Saarbrücker Personality Questionnaire (SPF)
The 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.
Time frame: Baseline
HEXACO personality inventory
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.
Time frame: Baseline
Defense Style Questionnaire (DSQ-40)
The 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".
Time frame: Baseline
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland