Pooling data from 10 placebo-controlled cross-over studies in 194 healthy volunteers, the authors found that MDMA plasma concentration—shaped by dose per body weight and CYP2D6 activity—was the strongest predictor of acute physiological and psychological effects. Personality and mood also contributed independently: higher openness predicted greater feelings of closeness and oceanic boundlessness, whereas high neuroticism or trait anxiety increased the likelihood of unpleasant or anxious reactions, with implications for therapeutic MDMA use.
Background
3,4-methylenedioxymethamphetamine (MDMA, “ecstasy”) is used both recreationally and therapeutically. Little is known about the factors influencing inter- and intra-individual differences in the acute response to MDMA. Effects of other psychoactive substances have been shown to be critically influenced by personality traits and mood state before intake.
Methods
We pooled data from 10 randomized, double-blind, placebo-controlled, cross-over studies performed in the same laboratory in 194 healthy subjects receiving doses of 75 or 125mg of MDMA. We investigated the influence of drug dose, body weight, sex, age, drug pre-experience, genetics, personality and mental state before drug intake on the acute physiological and psychological response to MDMA.
Results
In univariable analyses, the MDMA plasma concentration was the strongest predictor for most outcome variables. When adjusting for dose per body weight, we found that (a) a higher activity of the enzyme CYP2D6 predicted lower MDMA plasma concentration, (b) a higher score in the personality trait “openness to experience” predicted more perceived “closeness”, a stronger decrease in “general inactivation”, and higher scores in the 5D-ASC (5 Dimensions of Altered States of Consciousness Questionnaire) scales “oceanic boundlessness” and “visionary restructuralization”, and (c) subjects with high “neuroticism” or trait anxiety were more likely to have unpleasant and/or anxious reactions.
Conclusions
Although MDMA plasma concentration was the strongest predictor, several personality traits and mood state variables additionally explained variance in the response to MDMA. The results confirm that both pharmacological and non-pharmacological variables influence the response to MDMA. These findings may be relevant for the therapeutic use of MDMA.
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Bershad, A. K., Weafer, J. J., Kirkpatrick, M. G. et al. · Social Neuroscience (2016)
Carhart-Harris, R. L., Roseman, L., Haijen, E. C. H. M. et al. · Journal of Psychopharmacology (2018)
MDMA (3,4-methylenedioxymethamphetamine) is both a recreational drug and an investigational adjunct to psychotherapy, producing acute effects such as enhanced mood, openness, trust and empathy. Prior work has shown that responses to psychoactive substances are influenced not only by pharmacology (dose, pharmacokinetics, genetics) but also by non‑pharmacological factors often grouped as set (personality, mood, expectations) and setting (physical and social environment). Although several small studies have examined isolated predictors of MDMA response, few have jointly evaluated a broad range of pharmacological and non‑pharmacological factors while adjusting for confounders. Studerus and colleagues set out to quantify the relative contributions of multiple predictor domains to the acute physiological and psychological response to MDMA. Using pooled individual‑level data from 10 randomized, double‑blind, placebo‑controlled, cross‑over experiments performed in the same laboratory, the study aimed to test whether drug dose and exposure, demographic variables, prior drug experience, CYP2D6 genotype, personality traits and pre‑intake mood states predict acute MDMA effects. This is presented as the first comprehensive evaluation of such predictors in a single controlled dataset of healthy volunteers.
This pooled analysis combined raw data from 10 double‑blind, placebo‑controlled, cross‑over studies conducted at the University Hospital Basel between 2009 and 2018. The sample comprised 194 healthy volunteers (97 female) aged 18–45 years (mean 25.1 ± 4 years). Most participants were MDMA‑naïve or had only minimal prior use; exclusion criteria included psychiatric disorder, significant physical illness, and recent or heavy illicit drug use. All studies used washout periods of at least 7 days and the analysis used only the MDMA‑alone and placebo sessions. MDMA was administered orally as ±MDMA hydrochloride at single doses of either 75 mg or 125 mg; males and females received the same nominal doses. Dose per body weight (mean 1.7 ± 0.4 mg/kg, range 0.8–2.7 mg/kg) was treated as a covariate. Predictor variables included sex, age, dose per kg, number of prior MDMA uses, CYP2D6 genetic activity score, mood states before intake measured by the Adjective Mood Rating Scale (AMRS), personality traits from the NEO‑FFI (Neuroticism, Extraversion, Openness, Agreeableness, Conscientiousness), and trait anxiety from the STAI‑T. Primary response variables comprised pharmacokinetics (plasma MDMA concentrations sampled up to 6 h and summarised as AUC0–6h), autonomic measures (systolic/diastolic blood pressure, heart rate, tympanic temperature with peak values Emax used as outcomes), and multiple subjective measures. Subjective assessments included repeated Visual Analogue Scales (VAS) for constructs such as "any drug effect", "good/bad drug effect", "closeness" and "liking" with area under the effect‑time curve (AUEC) as the summary measure, AMRS repeated post‑drug, and the 5D‑ASC questionnaire administered 6 h post‑dose (etiology‑independent dimensions: Oceanic Boundlessness, Dread of Ego Dissolution, Visionary Restructuralization, plus constructed subscales for "impaired control and cognition" and "anxiety"). Statistical analysis used R. Missing data were multiply imputed (MICE) with 20 imputations; analyses were fitted in each completed dataset and pooled via Rubin’s rules except for LASSO models. To account for study clustering, linear mixed‑effects models with random intercepts for study were used. Predictor and response variables were z‑transformed; semi‑partial R2 quantified variance explained by fixed effects. P‑values were adjusted for multiple testing using the Benjamini‑Hochberg procedure. To identify parsimonious predictor sets and relative importance, LASSO regression (penalized package) was employed: optimal lambda was chosen via grid search and bootstrap estimation of out‑of‑bag mean squared error. LASSO models used single imputation and did not account for study clustering for simplicity.
In univariable (unadjusted) mixed models, MDMA plasma concentration (AUC0–6h) was the strongest predictor of both physiological and psychological outcomes. It was significantly associated with 16 of 24 outcome variables before multiple‑test correction and with eight after correction. The largest standardised associations (β, corrected p, semi‑partial R2) included VAS "any drug effect" (β = 0.48, corrected p < 0.001, R2 = 0.35), mean arterial pressure (β = 0.35, corrected p < 0.001, R2 = 0.25), VAS "liking" (β = 0.36, corrected p < 0.001, R2 = 0.17), VAS "good drug effects" (β = 0.35, corrected p < 0.001, R2 = 0.19), VAS "stimulated" (β = 0.30, corrected p = 0.001, R2 = 0.44), VAS "high mood" (β = 0.29, corrected p = 0.002, R2 = 0.43), AMRS "introversion" change (β = 0.24, corrected p = 0.032, R2 = 0.21), and 5D‑ASC "oceanic boundlessness" (β = 0.25, corrected p = 0.045, R2 = 0.06). Because plasma concentration is not available at the time of intake, subsequent adjusted models used drug dose per body weight as the pharmacological covariate. After adjustment and multiple‑testing correction, a genetically lower CYP2D6 activity predicted higher MDMA plasma concentration (β = -0.19, corrected p < 0.001, R2 = 0.10). Older age was associated with a smaller MDMA‑induced heart rate increase (β = -0.27, corrected p = 0.019, R2 = 0.07). Personality and mood predictors retained significant relationships with specific subjective outcomes: higher Openness predicted a stronger decrease in AMRS "general inactivation" (β = -0.25, corrected p = 0.042, R2 = 0.06), greater VAS "closeness" (β = 0.28, corrected p = 0.019, R2 = 0.08), and higher 5D‑ASC scores for "oceanic boundlessness" (β = 0.22, corrected p = 0.042, R2 = 0.06) and "visionary restructuralization" (β = 0.27, corrected p = 0.006, R2 = 0.09). Higher Neuroticism and higher trait anxiety (STAI‑T) predicted greater 5D‑ASC "dread of ego dissolution" (both β = 0.32; corrected p = 0.001 and 0.004; R2 = 0.12 and 0.11) and "impaired control and cognition" (both β = 0.26; corrected p = 0.014 and 0.042; R2 = 0.08 and 0.07). Pre‑intake AMRS "anxiety‑depressiveness" and "introversion" predicted higher 5D‑ASC "anxiety" scores (β = 0.25 and 0.23; corrected p = 0.042 and 0.042; R2 = 0.06 and 0.05). LASSO models selected, on average, 8.6 predictors per response (range 5–13). Dose per body weight was the most frequently selected predictor (identified for 21 of 25 response variables) and held the largest standardised coefficient for 12 outcomes, especially positive/neutral subjective measures and 5D‑ASC "oceanic boundlessness". By contrast, unpleasant or anxious reactions were better predicted by non‑pharmacological variables: older age, trait anxiety, pre‑intake anxiety‑depressiveness, and Neuroticism emerged as the most important predictors for "bad drug effects" and adverse 5D‑ASC subscales. Sex and prior MDMA use did not predict outcomes after adjusting for dose per kg.
Studerus and colleagues interpret the results as evidence that both pharmacological and non‑pharmacological factors influence acute MDMA effects, with pharmacokinetic exposure (plasma concentration) being the dominant predictor for many outcomes. Dose per body weight served as a practical proxy for plasma exposure and was frequently the most important predictor; CYP2D6 genotype additionally affected plasma concentration, consistent with known metabolic effects. Psychological responses showed differential patterns: higher Openness to experience amplified pleasant, prosocial and perceptual aspects of the MDMA experience (greater closeness, decreased inactivation, higher oceanic boundlessness and visionary restructuring), whereas higher Neuroticism and trait anxiety, and higher pre‑intake anxiety‑depressiveness or introversion, were associated with more anxious or challenging reactions (dread of ego dissolution, impaired control/cognition, 5D‑ASC anxiety). The authors note these relationships mirror findings from psychedelic studies and suggest an overlap in how set variables shape serotonergic drug responses. The discussion acknowledges limitations that constrain generalisability. The sample was young, healthy and largely MDMA‑naïve, so results may not translate directly to patient populations with psychiatric disorders or to heavier recreational users. Dose variety was limited (predominantly 125 mg), reducing exploration of dose–response heterogeneity. The standardised hospital research setting minimised variation in the physical and social environment, so setting effects could not be evaluated. Finally, the analysis focused on acute effects and cannot inform longer‑term outcomes. In terms of implications, the authors propose that awareness of both pharmacological factors (dose/kg, CYP2D6) and psychological traits/mood states could inform safety optimisation and preparation in MDMA‑assisted psychotherapy, for example by tailoring preparation and patient selection to reduce adverse reactions and enhance potentially therapeutic prosocial effects. They also highlight consistency with prior psychedelic research and the possibility that MDMA treatment itself may shift personality traits in therapeutic contexts.
The pooled analysis shows that MDMA response in healthy volunteers is shaped by both drug exposure and individual psychological characteristics. While dose per body weight (and resulting plasma concentration) explained much of the variance in positive and neutral effects, personality traits and pre‑intake mood—especially Openness, Neuroticism and state anxiety—contributed importantly to the likelihood of pleasant versus anxious experiences. These findings could inform the planning and safety considerations for MDMA‑assisted psychotherapy by guiding dosing decisions and psychological preparation.
All data were analyzed using the R language and environment for statistical computing (R Core Team, 2019). Since some of the predictor and response variables contained missing data (see Supplementary Table), we first performed multiple imputation (MI) using the Multivariate Imputation via Chained Equations (MICE) package in R (Buuren and Groothuis-Oudshoorn, 2010). We chose this method because it yields unbiased parameter estimates and standard errors under a "missing at random" (MAR) or "missing completely at random" (MCAR) missing data mechanism and maximizes statistical power by using all available information. The assumption of MAR was plausible in this study because the missing data mostly resulted from different study designs among the pooled studies. We generated 20 imputations of the missing values such that 20 completed datasets were obtained to avoid a potential power falloff from an insufficient number of imputations. The analyses of interest were then conducted in each completed data set and parameter estimates were pooled according to Rubin's rules, except for the LASSO models (see below). To account for the clustering in our data arising from pooling across studies, we used linear mixed effects models in which the intercepts were allowed to vary randomly across studies. For each combination of predictor and response variable, an adjusted and unadjusted model was fitted using the R package nlme. In the unadjusted model, only the predictor of interest was included in the fixed effects part of the model, whereas in the adjusted model "dose per body weight" was additionally included. Predictor and response variables were z-transformed before inclusion in the models, such that the estimated regression coefficients were fully standardized and comparable across predictors and responses. In each model, the amount of variance explained by each fixed effects predictor was determined by calculating the semi-partial R 2 using r2beta function in r2glmm package with the Kenward-Roger approach. To account for multiple testing, p-values were corrected across all significance tests using the Benjamini-Hochberg procedure. To identify the best subset of predictors for each response variable and to determine relative importance of these predictors, we applied the least absolute shrinkage and selection operator (LASSO) using the R package penalized. LASSO conducts both variable selection and regularization (i.e., shrinkage of regression coefficients) in order to optimize the predictive accuracy and interpretability of the model. It has been shown that variable selection with the LASSO is often more accurate than with traditional methods, such as stepwise methods. For each response variable, a LASSO model was developed according to the following procedure. First, the optimal shrinkage parameter of each model was determined by performing grid search. For each lambda in the grid, bootstrapping with 50 iterations was performed and the average predictive performance (i.e., mean squared error) across all out-of-bag samples was calculated using the machine learning in R (mlr) package. Second, the lambda value producing the highest out-of-bag predictive performance was chosen as the optimal lambda value and used for the final LASSO model fitted on the whole sample. Since it is currently unclear how to combine LASSO models across multiply imputed datasets and since the amount of missing data in our data set was relatively small, only single imputation was used for the LASSO models. Furthermore, for simplicity, we did not account for a potential clustering in our data in these analyses.
This study investigated the influence of 20 predictor variables on the physiological and psychological response to MDMA in healthy humans. We found that physiological as well as most psychological effects were most strongly dependent on MDMA plasma levels, which in turn was most strongly dependent on drug dose and body weight. When adjusted for drug dose per body weight and corrected for multiple testing, only age and the genetically determined activity of the enzyme CYP2D6 had an influence on the physiological response to MDMA. Specifically, younger subjects responded to MDMA with a stronger increase in heart rate than older subjects and a higher activity of the enzyme CYP2D6 predicted lower MDMA plasma concentration. With regard to psychological effects, subjects with a high score in "openness to experience" responded with more "closeness", a stronger decrease in "general inactivation" and higher scores in the 5D-ASC scales "oceanic boundlessness" and "visionary restructuralization" in response to MDMA, whereas subjects with high "neuroticism" or trait anxiety experienced more "anxious ego dissolution" and "impaired control and cognition". Furthermore, being more anxious-depressive or introverted immediately before MDMA intake was associated with more anxiety in response to MDMA. Our finding that the MDMA plasma concentration -and indirectly MDMA dose per body weight -is the most important predictor for the response to MDMA is in line previous dose-response studies. However, as can be seen in Supplementary Figure, there were also several outcome variables that were not or only weakly predicted by MDMA plasma concentration. In general, MDMA plasma level tended to be most predictive for positive or neutral MDMA effects, as measured by the VAS scales "any drug effects", "good drug effects", "liking" and "stimulated" or the 5D-ASC scale "oceanic boundlessness", and less so for negatively experienced MDMA effects, such as the VAS scale "bad drug effects" or the 5D-ASC scales "anxiety", "impaired control and cognition" or "anxious ego dissolution". This supports the study of, which found that MDMA dose correlated with subjective "energy level", "feelings of closeness to others", "mind racing", "heightened senses" and "high", but not with "ability to concentrate". We also found that the MDMA plasma concentration was positively associated with mean arterial blood pressure and heart rate, but not with body temperature, which is again in line with the study of. To investigate the effects of all other predictors adjusted for the amount of drug, we used drug dose per body weight rather than MDMA plasma concentration as a covariate since the latter is not known in advance and unlikely to be determined in the clinical setting. Drug dose per body weight was shown to be a good proxy for MDMA plasma concentration, because, when adjusting for drug dose per body weight, only the geneticallydetermined enzyme CYP2D6 activity contributed to the prediction of MDMA plasma concentration. In line with this finding, CYP2D6 poor metabolizers have previously been shown to have higher blood plasma concentrations than extensive/normal metabolizers (de la. After adjusting for drug dose per body weight, sex did not significantly influence the effects of MDMA indicating that the stronger response in women as shown in the unadjusted analyses was due to lower body weight and correspondingly higher drug dose per body weight in women. Thus, this study could not confirm earlier studies reporting sex-differences in acute physiological and subjective responses to MDMA even after adjusting for body weight (for review, see. For example,reported that women experienced both more intense positive and negative subjective drug effects, but particularly perceptive changes, thought disturbances, and fear of loss of body control, whereas men showed a higher increase in blood pressure in response to MDMA. Other studies suggested that women may be particularly vulnerable to acute negative subjective and cardiovascular, acute biologicaland subacute negative effects of MDMA. On the other hand, the largest study to date including 220 individuals (44% female) from three different laboratories, who had received MDMA in controlled experiments, could not detect any gender differences in acute cardiovascular and subjective responses to MDMA in line with the current study. A more consistent effect was observed for age, which inversely correlated with the MDMA-induced heart rate elevation. This finding might be explained by an age-associated decrease of adrenergic receptor sensitivity and density in cardiac muscleand supports the theory of an adrenergic receptor mediated cardiovascular effect of MDMA that can be inhibited by carvedilol. However, we do not think that this relationship is of high clinical relevance or use in practice. Our data also suggested that older age was associated with a lower increase in body temperature, less "liking", "good drug effects" and decrease in "general inactivation" and more "bad drug effects". An increase in "bad drug effects" with older age would be in contrast to the response to the psychedelic drug psilocybin, which has been shown to be more often challenging in younger age. However, these associations should be interpreted cautiously as they did not withstand correction for multiple testing and result from a rather limited dataset in terms of age variation. Individuals over 45 were excluded from the study and could react differently, especially since comorbidities also increase with age. Previous MDMA experience showed no moderating effect on the response to MDMA in our study, which was rather surprising since recreational MDMA users frequently report experiencing the strongest effects the first time they ever tried MDMAand developing tolerance to the positive subjective effects of MDMA over time. Accordingly, one laboratory based multicenter study has found modest evidence that greater prior use of MDMA is associated with lesser ratings of feeling any drug effect. However, this association was not consistently observed across all study centers and a further laboratorybased study could also not detect it. It is important to note that in the present study, 79% of subjects were MDMA naïve and the others had a maximum of only five previous MDMA experiences. Therefore, the influence of heavier past MDMA use could not be assessed in the present study. Notably, patients in clinical trials using MDMA will, similar to the present study population, likely have no to little experience in using MDMA, enhancing the relevance of the present data for the clinical situation. In contrast, the majority of other controlled studies using MDMA in healthy subjects has been conducted in persons with considerably greater MDMA use in the past. Regarding the influence of personality, we found that subjects with more "openness to experience" experienced more "closeness", a stronger decrease in "general inactivation" and more "oceanic boundlessness" and "visionary restructuralization" in response to MDMA. "Oceanic boundlessness", as measured by the 5D-ASC questionnaire, describes happiness-inducing aspects of the experience and includes experiences of oneness with the self and the world and liberation from the restrictive aspects of space and time, whereas "visionary restructuralization" covers phenomena of altered perception and meaning. Our finding that "openness to experience" is positively associated with these subjective effects of MDMA is consistent with its conceptual overlap with the personality traits of "absorption", which is associated with differential responsivity to various ASC induction procedures, including hypnosis, meditation, cannabis and electromyograph biofeedback. Accordingly, "absorption" has also shown to be one of the most important predictors of pleasant and "mystical-type" experiences in response to psychedelic drugs, including psilocybinand ayahuasca. While more "openness to experience" seemed to intensify pleasant and prosocial effects of MDMA, we found that more pronounced "neuroticism" or "trait anxiety" led to more "dread of ego dissolution" and "impaired control and cognition" in response to MDMA. Furthermore, a higher score in "anxiety-depressiveness" or "introversion" immediately before MDMA intake increased the likelihood of anxious responses to MDMA. This is again consistent with the responsivity to psychedelic drugs, since a higher score in "neuroticism" trait or "emotional excitability" before drug administration were found to forecast more "challenging experiences" after taking psychedelic substances. However, it should be noted that anxiety scores in response to MDMA relative to other subjective response measures are rather small and only 7% of subjects reported anxiety as an acute adverse effect in the high dose condition (i.e., 125mg). Thus, challenging experiences are considered less likely to occur after MDMA than after high dose of psychedelics. While this study suggests that personality traits such as "openness to experience" and "neuroticism" influence the MDMA experience, there is some indication that the effect goes in the opposite direction too and that this may potentially act as a therapeutic mechanism of change. For example, it has been found that MDMA-assisted psychotherapy in patients with Post-Traumatic Stress Disorder (PTSD) led to long-lasting increased "openness to experience" and decreased "neuroticism" and that changes in "openness to experience" but not "neuroticism" played a moderating role in the relationship between reduced PTSD symptoms and MDMA treatment. A similar persisting effect on personality traits was also observed after the ingestion of psilocybin or LSD. Thus, the finding that subjects who take MDMA with an "open mind" display more potentially therapeutic beneficial effects could suggest that patients progressively benefit from multiple MDMA-assisted psychotherapy sessions, as they likely become more open to the experience over time.
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